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Start PreambleStart Printed Page 28162

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Proposed rule.

SUMMARY:

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 27, 2016.

ADDRESSES:

In commenting, please refer to file code CMS-5517-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786 7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Molly MacHarris, (410) 786-4461, for inquiries related to MIPS.

James P. Sharp, (410) 786-7388, for inquiries related to APMs.

End Further InfoEnd PreambleStart Supplemental Information

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Acronyms

Because of the many terms to which we refer by acronym in this proposed rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:

ABCTM Achievable Benchmark of Care

ACA The Patient Protection and Affordable Care Act

ACO Accountable Care Organization

APM Alternative Payment Model

BPCI Bundled Payments for Care Improvement

CAH Critical Access Hospital

CAHPS Consumer Assessment of Healthcare Providers and Systems

CEHRT Certified EHR technology

CFR Code of Federal Regulations

CHIP Children's Health Insurance Program

CJR Comprehensive Care for Joint Replacement

CMMI Center for Medicare & Medicaid Innovation (Innovation Center)

CPIA Clinical Practice Improvement Activity

CPR Customary, Prevailing, and Reasonable

CPS Composite Performance Score

CPT Current Procedural Terminology

CQM Clinical Quality Measure

EHR Electronic heath record

EP Eligible professional

FFS Fee-for-Service

FQHC Federally Qualified Health Center

HIE Health Information Exchange

HIPAA Health Insurance Portability and Accountability Act of 1996

HITECH Health Information Technology for Economic and Clinical Health

HPSA Health Professional Shortage Area

HHS Department of Health & Human Services

HRSA Health Resources and Services Administration

IT Information technologyStart Printed Page 28163

MACRA Medicare Access and CHIP Reauthorization Act of 2015

MEI Medicare Economic Index

MIPAA Medicare Improvements for Patients and Providers Act of 2008

MIPS Merit-Based Incentive Payment System

MLR Minimum Loss Rate

MSPB Medicare Spending per Beneficiary

MSR Minimum Savings Rate

MUA Medically Underserved Area

NPI National Provider Identifier

OCM Oncology Care Model

ONC Office of the National Coordinator for Health Information Technology

PECOS Medicare Provider Enrollment, Chain, and Ownership System

PFPMs Physician Focused Payment Models

PFS Physician Fee Schedule

PHS Public Health Service

PQRS Physician Quality Reporting System

QCDRs Qualified Clinical Data Registries

QP Qualifying APM Professional

QRDA Quality Reporting Document Architecture

QRUR Quality and Resource Use Reports

RBRVS Resource-Based Relative Value Scale

RHC Rural Health Clinic

RVU Relative Value Unit

SGR Sustainable Growth Rate

TCPI Transforming Clinical Practice Initiative

TIN Tax Identification Number

VM Value-based Payment Modifier

VPS Volume Performance Standard

Table of Contents

Executive Summary

I. Background

A. Physician and Practitioner Payment Under Medicare

B. Current Reporting Programs and Regulations (Overview)

C. Overview of Section 101 of the MACRA

D. Stakeholder Input

II. Provisions of the Proposed Regulations

A. Establishing MIPS and the APMs Incentive

B. Program Principles and Goals

C. Changes to Existing Programs

D. Definitions

E. MIPS Program Details

F. Incentive Payments for Participating in Advanced APMs

III. Collection of Information Requirements

IV. Response to Comments

V. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Changes in Medicare Payments

D. Impact on Beneficiaries

E. Impact on Other Health Care Programs and Providers

F. Alternatives Considered

G. Assumptions and Limitations

H. Accounting Statement

Executive Summary

1. Purpose

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015), amended title XVIII of the Social Security Act (the Act) to repeal the Medicare sustainable growth rate and strengthen Medicare access by improving physician payments and making other improvements, to reauthorize the Children's Health Insurance Program (CHIP), and for other purposes. This rule is needed to propose policies to improve physician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in alternative payment models.

This proposed rule would establish the Merit-Based Incentive Payment System (MIPS), a new program for certain Medicare-participating practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for eligible professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs), supporting the Administration's goals of moving more fee-for-service payments into APMs that focus on better care, smarter spending, and healthier people. This proposed rule also includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations to the Secretary on physician-focused payment models (PFPMs).

In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders. We discuss these terminology changes in greater detail in the following sections of this proposed rule.

2. Summary of the Major Provisions

This proposed rule would sunset payment adjustments under the current PQRS, VM, and the Medicare EHR Incentive Program for EPs. Components of these three programs would be carried forward into the new MIPS program.

This proposed rule would establish a new subpart O of our regulations at 42 CFR 414.1300 to implement the new MIPS program as required by the MACRA.

(a) MIPS

In establishing MIPS, this rule would define MIPS program participants as “MIPS eligible clinicians” rather than “MIPS EPs” as that term is defined at section 1848(q)(1)(C) and used throughout section 1848(q) of the Act. MIPS eligible clinicians will include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians. The rule proposes definitions and requirements for groups. In addition to proposing definitions for MIPS eligible clinicians, the rule also proposes rules for the specific Medicare-enrolled practitioners that would be excluded from MIPS, including newly Medicare-enrolled eligible clinicians, Qualifying APM Participants (QPs), certain Partial Qualifying APM Participants (Partial QPs), and clinicians that fall under the proposed low-volume threshold.

This rule proposes MIPS performance standards and a MIPS performance period of 1 calendar year (January 1 through December 31) for all measures and activities applicable to the four performance categories. Further, we propose to use 2017 as the performance period for the 2019 payment adjustment. Therefore, the first performance period would start in 2017 for payments adjusted in 2019. This time frame is needed to allow data and claims to be submitted and data analysis to occur. In addition, it would allow for a full year of measurement and sufficient time to base adjustments on complete and accurate information.

As directed by the MACRA, this rule proposes measures, activities, reporting, and data submission standards across four performance categories: Quality, resource use, clinical practice improvement activities (CPIAs), and meaningful use of certified EHR technology (referred to in this proposed rule as “advancing care information”). Measures and activities would vary by category and include outcome measures, performance measures, and global and population-based measures. Consideration would be given to the application of measures to non-patient facing MIPS eligible clinicians.

Quality measures would be selected annually through a call for quality measures process. Selection of these measures is proposed to be based on certain criteria that align with CMS priorities, and a final list of quality measures will be published in the Federal Register by November 1 of each year. Under the standards proposed in this rule, there would be options for reporting as an individual MIPS eligible Start Printed Page 28164clinician or as part of a group. Some data could be submitted via relevant third party data submission entities, such as qualified clinical data registries (QCDRs), health IT vendors,[1]
qualified registries, and CMS-approved survey vendors.

Within each performance category, we propose some specific standards, including:

Quality: For most MIPS eligible clinicians, we propose to include a minimum of six measures with at least one cross-cutting measure (for patient-facing MIPS eligible clinicians) and an outcome measure if available; if an outcome measure is not available, then the eligible clinician would report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. MIPS eligible clinicians can meet this criterion by selecting measures either individually or from a specialty-specific measure set.

Resource Use: Continuation of two measures from the VM: Total per costs capita for all attributed beneficiaries and Medicare Spending per Beneficiaries (MSPB) with minor technical adjustments. In addition, episode-based measures, as applicable to the MIPS eligible clinician.

CPIA: We generally encourage but are not requiring a minimum number of CPIAs.

We propose standards for measures, scoring, and reporting for MIPS eligible clinicians across all four performance categories outlined in this section. We propose that MIPS eligible clinicians who participate in certain types of APMs will be scored using an APM scoring standard instead of the generally applicable MIPS scoring standard.

The U.S. Department of Health & Human Services' (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) is conducting studies and making recommendations on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act) and expects to issue a report to Congress by October 2016. We will closely examine the recommendations issued by ASPE and incorporate them, as feasible and appropriate, in future rulemaking.

We are proposing MIPS eligible clinicians have the flexibility to submit information individually or via a group or an APM Entity group; however, the MIPS eligible clinician would use the same identifier for all performance categories. The proposed scoring methodology has a unified approach across all performance categories, would allow MIPS eligible clinicians to know in advance what they need to do to perform well in MIPS, and eliminates the need for an “all or nothing” scoring as has been the case under some other CMS programs. The four performance category scores (quality, resource use, CPIA, and advancing care information) would be aggregated into a MIPS composite performance score (CPS). The MIPS CPS would be compared against a MIPS performance threshold. The CPS would be used to determine whether a MIPS eligible clinician receives an upward payment adjustment, no payment adjustment, or a downward payment adjustment as appropriate. Payment adjustments would be scaled for budget neutrality, as required by statute. The CPS would also be used to determine whether a MIPS eligible clinician qualifies for an additional positive adjustment factor for exceptional performance.

To ensure that MIPS results are useful and accurate, we propose a process for providing performance feedback to MIPS eligible clinicians. Beginning July 1, 2017, we propose to include information on the quality and resource use performance categories in the performance feedback. Initially, we propose to provide performance feedback on an annual basis. In future years, we may consider providing performance feedback on a more frequent basis as well as adding feedback on the performance categories of CPIA and advancing care information. We propose to make performance feedback available using a CMS designated system. Further, we propose to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians where applicable.

We propose to adopt a targeted review process under MIPS wherein a MIPS eligible clinician may request that we review the calculation of the MIPS adjustment factor and, as applicable, the calculation of the additional MIPS adjustment factor applicable to such MIPS eligible clinician for a year. We further propose a general process by which a MIPS eligible clinician could request targeted review.

We propose requirements for third-party data submission to MIPS. Specifically, qualified registries, QCDRs, health IT vendors, and CMS-approved survey vendors would have the ability to act as intermediaries on behalf of MIPS eligible clinicians and groups for submission of data to us across the quality, CPIA, and advancing care information performance categories.

We also propose a process for public reporting of MIPS information through the Physician Compare Web site. We propose public reporting of a MIPS eligible clinician's data; in that for each program year, we will post on a public Web site (for example, Physician Compare), in an easily understandable format, information regarding the performance of MIPS eligible clinicians or groups under the MIPS.

(b) APMs

In this rule, we propose standards we would use for the purposes of the Alternative Payment Model (APM) incentive. The MACRA defines APM for the purposes of the incentive as a model under section 1115A of the Social Security Act (the Act) (excluding a health care innovation award), the Shared Savings Program under section 1899 of the Act, a demonstration under section 1866C of the Act, or a demonstration required by federal law. We propose to define the term “Other Payer APMs” to refer to arrangements in which eligible clinicians may participate through other payers. We also propose to define the term APM Entity as an entity that participates in an APM through a contract with a payer.

APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians can become QPs and earn incentive payments for participation in APMs as specified under the MACRA. This rule proposes two types of Advanced APMs: Advanced APMs and Other Payer Advanced APMs. To be an Advanced APM, an APM must meet three requirements: (1) Require participants to use certified EHR technology; (2) provide payment for covered professional services based on quality Start Printed Page 28165measures comparable to those used in the quality performance category of MIPS; and (3) be either a Medical Home Model expanded under section 1115A of the Act or bear more than a nominal amount of risk for monetary loses. In this rule, we propose criteria for each of the requirements to be an Advanced APM.

To be an Other Payer Advanced APM, a commercial or Medicaid APM must meet three requirements similar to the CMS Advanced APM requirements: (1) Require participants to use certified EHR technology; (2) provide payment based on quality measures comparable to those used in the quality performance category of MIPS; and (3) be either a Medicaid Medical Home Model that is comparable to Medical Home Models expanded under section 1115A of the Act or bear more than a nominal amount of risk for monetary loses.

We propose that we would notify the public of which APMs will be Advanced APMs prior to each QP Performance Period, starting no later than January 1, 2017. This information will be posted on our Web site.

The MACRA sets a Medicare threshold for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. The Medicare Option, based on Part B payments for covered professional services or counts of patients furnished covered professional services under Part B, is applicable beginning with CY 2019. The All-Payer Combination Option, based on the Medicare Option, as well as an eligible clinician's participation in Other Payer Advanced APMs, is applicable beginning with CY 2021. For eligible clinicians to become QPs through the All-Payer Combination Option, an Advanced APM Entity or eligible clinician must submit information to us so that we can determine whether an Other Payer APM is an Other Payer Advanced APM and whether an eligible clinician meets the requisite QP threshold of participation. We propose a methodology and criteria to evaluate eligible clinicians using the All-Payer Combination Option. For purposes of evaluating Other Payer APMs, we also propose criteria for the definition of Medicaid Medical Homes and Medical Home Model.

We propose to identify individual eligible clinicians by a unique APM participant identifier using the individuals' TIN/NPI combinations, and to assess as an APM Entity group all individual eligible clinicians listed as participating in an Advanced APM Entity to determine QP status for a year. We also propose that if an individual eligible clinician who participates in multiple Advanced APM Entities does not achieve QP status through participation in any single APM Entity, we would assess the eligible clinician individually to determine QP status based on combined participation in Advanced APMs.

We propose the method that CMS would use to calculate and disburse the APM Incentive Payments to QPs. We propose specific rules for calculating the APM Incentive Payment when a QP also receives non-fee-for-service payments or payment adjustments through the Medicare EHR Incentive Program, PQRS, VM, MIPS, or other payment adjustment programs.

We propose a process for eligible clinicians to choose whether or not to be subject to the MIPS payment adjustment in the event that they are determined to be Partial QPs.

We propose that we would perform monitoring and compliance around APM Incentive Payments.

We propose a definition for Physician-Focused Payment Models (PFPMs), criteria that would be used by the PFPM Technical Advisory Committee (PTAC), the Secretary, and CMS to evaluate proposals for PFPMs, and the process by which PFPMs would be considered for testing and implementation by CMS after review by the PTAC.

We propose to require MIPS eligible clinicians, as well as EPs, eligible hospitals, and Critical Access Hospitals (CAHs) under the existing EHR Incentive Programs to make a demonstration related to the provisions concerning blocking the sharing of information under section 106(b)(2) of the MACRA and, separately, to demonstrate cooperation with authorized ONC surveillance of certified EHR technology.

3. Summary of Costs & Benefits

Under the MACRA's requirements, MIPS would distribute payment adjustments to between approximately 687,000 and 746,000 eligible clinicians in 2019. Payment adjustments would be based on MIPS eligible clinicians' performance on specified measures and activities within the four performance categories. We estimate that MIPS payment adjustments would be approximately equally distributed between negative adjustments ($833 million) and positive adjustments ($833 million) to MIPS eligible clinicians, to ensure budget neutrality. Additionally, MIPS would distribute approximately $500 million in exceptional performance payments to MIPS eligible clinicians whose performance exceeds a specified threshold. These payment adjustments are expected to drive quality improvement in the provision of MIPS eligible clinicians' care to Medicare beneficiaries and to all patients in the health care system. However, the distribution could change based on the final population of MIPS eligible clinicians for CY 2019 and the distribution of scores under the program.

We estimate that between approximately 30,658 and 90,000 eligible clinicians would become QPs through participation in Advanced APMs, and are estimated to receive between $146 million and $429 million in APM Incentive Payments for CY 2019. As with MIPS, we expect that APM participation would drive quality improvement for clinical care provided to Medicare beneficiaries and to all patients in the health care system.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) of 2015 (Pub. L. 114-10, enacted April 16, 2015, and hereafter referred to as the MACRA), landmark bipartisan legislation, advances a forward-looking, coordinated framework for health care providers to successfully take part in the CMS Quality Payment Program that rewards value and outcomes in one of two ways:

Merit-Based Incentive Payment System (MIPS).

Advanced Alternative Payment Models (Advanced APMs).

The MACRA marks a milestone in efforts to improve and reform the health care system. Building off of the successful coverage expansions and Start Printed Page 28166improvements to access under the Affordable Care Act, the MACRA puts an increased focus on the quality and value of care delivered. By incentivizing participation in certain APMs, such as Accountable Care Organizations (ACOs), Medical Home Models, and episode payment models, and by incentivizing quality and value for eligible clinicians under the MIPS, we support the nation's progress toward achieving a patient-centered health care system that delivers better care, smarter spending, and healthier people and communities.

The Department is focused on three core strategies to drive continued progress and improvement, and MACRA provides new tools to that end, which build upon existing efforts, such as the CMS Quality Strategy [2]
. First, we are focused on improving the way clinicians are paid to incentivize quality and value of care over simply quantity of services. The Quality Payment Program replaces the SGR update formula with Medicare PFS updates ultimately linked to participation in Advanced APMs and also creates a new, sustainable mechanism for calculating payment adjustments for clinicians' services that links payments to quality and value: The Merit-based Incentive Payment System (MIPS), with the ultimate goal of paying for value and better care. By rewarding eligible clinicians based on their performance, MIPS consolidates key components of the PQRS, the VM and the Medicare EHR Incentive Program for EPs into one single, streamlined program based on performance in the following:

Quality.

Resource use.

CPIA.

Advancing care information.

Second, we are focused on improving the way care is delivered by providing clinical practice support, data and feedback reports to guide improvement and better decision-making. Allowing for stronger, real-time, easy-to-understand feedback and actionable data on eligible clinician performance on clinical quality measures (CQMs), utilization of resources and cost can lead to stronger care coordination, help facilitate and enhance team-based approaches, and support greater integration within practices, improved patient communication, a stronger focus on population health, and continuous learning and rapid-cycle improvement.

Third, we are focused on making data more available and enabling the use of certified EHR technology to support care delivery. Consistent use of certified EHR technology and clinical quality measurement in managing patient populations would help lead to substantial improvements in our health care system, by allowing clinicians to track and take care of their patients throughout the care continuum and to easily and securely access electronic health information to support care when and where it is needed.

By driving significant changes in how care is delivered and changes in the health care system to make it more responsive to patients and families, we believe the Quality Payment Programs would encourage eligible clinicians to be accountable for the health of their patient population and support interested eligible clinicians in their successful transition into APMs. To implement this vision, we propose a program that allows for stronger alignment across requirements while minimizing burden on eligible clinicians. Further, we propose a program that is meaningful, understandable and flexible with a critical focus on transparency, effective communication with stakeholders and operational feasibility. To aid in this process, we have sought feedback from the health care community through various public avenues and will seek comment through this proposed rule. As we establish policies for effective implementation of the MACRA, we are also focused on improving the health system by ensuring that our policies can scale in future years. As we drive change through this proposed rule, we will begin by laying the groundwork for expansion towards an innovative, outcome-focused, patient-centered, resource-effective health system. Through a staged approach we can develop our policies are operationally feasible and made in consideration of system capabilities and of our core strategies to drive progress and reform efforts.

A. Physician and Practitioner Payment Under Medicare

1. History

Medicare payment systems have undergone significant changes since the Act established the Medicare program in 1965. Originally, Medicare was modeled on the existing health insurance marketplace (See 1965 Medicare Amendment to SSA, Pub. L. 89-97). Medicare payments to physicians and hospitals were based on the amounts that had been historically charged by physicians and hospitals for various health care services. Medicare initially paid for physicians' services using a “customary, prevailing, and reasonable” charge (CPR) payment system. (1965 Medicare Amendment to SSA, Pub. L. 89-97). Congress later changed the CPR system in part to counter increased charges to physicians, leading to rapid increases in program payments.

In 1984, Medicare changed the way it paid hospitals to a prospective payment system (Social Security Amendments of 1983, Pub. L. 98-21) that moved away from a charge-based per diem rate and introduced the Medicare Economic Index (MEI) to modify physician payment. The MEI was used to measure the annual increase in practice costs for updating payment for physicians' services.

Beginning in 1992 following the passage of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) (Pub. L. 101-239, enacted on December 19, 1989), the historical charge-based fee schedule was replaced with a fee schedule that used a Resource-Based Relative Value Scale, developed at Harvard University, which attempted to assess for each service the relative value of a physician's work effort, as well as the practice expenses and malpractice liability expenses involved.

Under OBRA 89, the resource-based Medicare PFS aimed to establish a rational basis for valuing payments for physicians' services. Therefore, under the current resource-based approach, payment for a service depends on the value of the resources involved in performing a particular service.

Following the implementation of the resource-based PFS over several years, the fee schedule has specified Medicare payments for physicians' services. Each medical, surgical and diagnostic service, described by a current procedural terminology (CPT) code is assigned relative value units (RVUs) for three resource categories: Work, practice expense, and malpractice expense. These three RVU values are summed, geographically adjusted, and multiplied by a fixed-dollar conversion factor for the payment year to determine the payment amount for each service or procedure. Over time, we have reviewed and revised the RVU values using our own methodologies and other information.

After the adoption of the resource-based PFS, further amendments to the Act have led to the imposition of spending targets for physicians' services. Initially, the spending limit was set by a Volume Performance Standard (VPS) that tied the annual update to a target that was based on historical trends in physician costs. Because of the way the adjustment was Start Printed Page 28167calculated, it produced very unstable updates, with swings that were much greater than the changes in the underlying MEI.

The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) replaced the VPS with the SGR formula to update the PFS each year. Under BBA, the SGR made several changes including a much more aggressive measure to control spending, tying the allowable increases in physician spending to the growth rate in real GDP per capita. In general, under the SGR formula, if cumulative expenditures from the current period going back to 1996 (the base year) were less than the cumulative spending target over that same period, the annual update was increased according to a statutory formula. However, if spending exceeded the cumulative spending target over the same period, the SGR methodology requires reductions in the fee schedule update to bring spending back in line with the targeted growth rate.

In the initial years of implementation, actual expenditures did not exceed allowed targets. But beginning in 2002, cumulative actual expenditures began to exceed allowed targets for the year, resulting in SGR-mandated reductions in the fee schedule update adjustment factor. The Congress enacted a series of laws to override these reductions. The SGR-based update adjustment factor had not been allowed to take effect since 2003 due to consistent intervention by the Congress to avert payment reductions.

Currently, payments under the Medicare PFS include several payment adjustments that increase or decrease payments to practitioners based on performance. The Tax Relief and Health Care Act of 2006 required the establishment of the PQRS that would include an incentive payment to EPs who satisfactorily report data on quality measures. The Medicare Improvements for Patients and Provider Act of 2008 (MIPPA) (Pub. L. 110-275, enacted on July 15, 2008) made the PQRS program permanent. The HITECH Act of 2009, part of the American Recovery and Reinvestment Act (ARRA), established incentive payments to EPs to promote the adoption and meaningful use of certified EHR technology. HITECH provided the statutory basis for the Medicare incentive payments made to meaningful EHR users and also established downward payment adjustments, under Medicare, beginning with calendar year 2015, for EPs that are not meaningful users of certified EHR technology for certain associated reporting periods.

The Affordable Care Act (Pub. L. 111-148) required the establishment of a value-based payment modifier that provides for differential payment to a physician or group of physicians under the Medicare PFS based upon the quality of care furnished compared to cost, that is implemented in a budget-neutral manner. Beginning in 2015, the VM applies to payments for items and services furnished by physicians in groups of 100 or more, and will apply to all physicians and certain types of non-physician practitioners in later years. The VM is being phased in and will apply to all physicians in groups and individual physicians in 2017.

2. Payment Models and Innovation

The policies proposed in this rule are intended to continue to move Medicare away from a primarily volume based fee-for-service (FFS) payment system for physicians and other professionals. As described in this section of the proposed rule, for many years Medicare was primarily a FFS payment system that paid health care providers based on the volume of services they delivered, rather than the value of those services. This contributed to increased costs without incentivizing improvement in the quality of care. Over time, the Congress and CMS have taken progressive steps to move toward paying for value, as demonstrated by Medicare's long history of testing alternative payment methods.

Medicare has been testing alternative payment methods since waiver authority for Medicare demonstrations was granted through section 402 of the Social Security Amendments of 1967. Demonstrations and pilot programs, (also called “research studies”) are special projects that test improvements in Medicare coverage, payment, and quality of care (https://www.medicare.gov/​sign-up-change-plans/​medicare-health-plans/​other-health-plans/​other-medicare-health-plans.html). Demonstrations have examined whether alternative payment methods increase the efficiency of Medicare and Medicaid and whether payment for services not otherwise covered increases the effectiveness of care. Medicare's demonstration authority has allowed it to test the effect of policy changes on Medicare on a small scale in order to inform broader policy.

The Affordable Care Act includes a number of provisions, for example, the Medicare Shared Savings Program, designed to improve the quality of Medicare services, support innovation and the establishment of new payment models, better align Medicare payments with health care provider costs, strengthen Medicare program integrity, and put Medicare on a firmer financial footing.

The Affordable Care Act created the Center for Medicare and Medicaid Innovation (Innovation Center). The Innovation Center was established by section 1115A of the Act (as added by section 3021 of the Affordable Care Act). The Innovation Center's mandate gives it flexibility within the parameters of section 1115A of the Act to select and test promising innovative payment and service delivery models. Congress created the Innovation Center for the purpose of testing innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care provided to those individuals who receive Medicare, Medicaid, or CHIP benefits. See https://innovation.cms.gov/​about/​index.html. Models that have met those expectations may be expanded in scope through rulemaking up to a national scale.

To better coordinate these models and demonstration projects and to avoid duplicative efforts and expenses, the former Office of Research, Development and Information, which oversaw statutory demonstrations and those under section 402 etc., was merged with the Innovation Center in early 2011. As a result, the Innovation Center oversees not only initiatives that are authorized under section 1115A of the Act, but also activities under several other authorities, including other provisions of the Affordable Care Act, and other laws and projects authorized by section 402 of the Social Security Amendments of 1967, as amended.

The Innovation Center's portfolio of models has attracted participation from a broad array of health care providers, states, payers, and other stakeholders, and serves Medicare, Medicaid, and CHIP beneficiaries in all 50 states, the District of Columbia, and Puerto Rico. We estimate that over 4.7 million Medicare, Medicaid, and CHIP beneficiaries are or soon will be receiving care furnished by the more than 61,000 eligible clinicians participating in APMs tested by the CMS Innovation Center.

Beyond the care improvements for these beneficiaries, Innovation Center models are affecting millions of additional Americans by engaging thousands of other health care providers, payers, and states in model tests and through quality improvement efforts across the country. Many payers other than CMS have implemented alternative payment arrangements or models, or have collaborated in Start Printed Page 28168Innovation Center models. The participation of multiple payers in alternative delivery and payment models increases momentum for delivery system transformation and encourages efficiency for health care organizations.

The Innovation Center works directly with other CMS components and colleagues throughout the federal government in developing and testing new payment and service delivery models. Other federal agencies with which the Innovation Center has collaborated include the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), Agency for Healthcare Research and Quality (AHRQ), Office of the National Coordinator for Health Information Technology (ONC), Administration for Community Living (ACL), Department of Housing and Urban Development (HUD), Administration for Children and Families (ACF), and the Substance Abuse and Mental Health Services Administration (SAMHSA). These collaborations help the Innovation Center effectively test new models and execute mandated demonstrations.

B. Current Reporting Programs and Regulations (Overview)

The MACRA's passage has led to several changes with the existing Medicare PFS, various Medicare payment programs that tie payment to value, and the testing of alternative payment models. Specifically, the MACRA's enactment consolidated aspects of certain quality reporting and performance programs into the new MIPS, including the meaningful use of certified EHR technology (section 1848(o) of the Act), the PQRS (section 1848(k) and (m) of the Act, and the VM (section 1848(p) of the Act). The following section provides an overview of existing programs and the extent of their programs before and after the MACRA.

Currently, the Medicare EHR Incentive Program has been divided into three progressive stages of meaningful use with certain specified requirements that EPs must meet in order to qualify for Medicare EHR incentive payments and avoid downward payment adjustments. Full achievement of these requirements designated an EP as a “meaningful EHR user” and made that EP eligible for incentive payments and not subject to downward payment adjustments. The MACRA's enactment altered the EHR Incentive Programs such that the existing Medicare payment adjustment for an EP under 1848(a)(7)(A) of the Act ends after CY 2018. Using certified EHR technology is included in MIPS as part of the advancing care information component of the overall performance score. Generally, the MACRA did not change hospital participation in the Medicare EHR Incentive Program or participation for EPs in the Medicaid EHR Incentive Program.

PQRS, as set forth in sections 1848(a), (k), and (m) of the Act, is a quality reporting program that provides for incentive payments (which ended in 2014) and payment adjustments (which began in 2015) to EPs and group practices based on whether they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period or to EPs and group practices based on whether they satisfactorily participate in a qualified clinical data registry (QCDR). The MACRA ends the PQRS adjustment after CY 2018 and provides for the inclusion of various aspects of PQRS in MIPS as part of the quality component of the overall performance score.

Section 1848(p) of the Act, as amended by the Affordable Care Act, required that we establish a VM that provides for differential payment under the Medicare PFS based upon the quality of care furnished compared to cost and apply it to specific physicians and groups of physicians as determined appropriate by the Secretary starting in 2015 and to all physicians by 2017. In the CY 2013 PFS final rule with comment period (77 FR 69307), we discussed the goals of the VM and also established the specific principles that should govern the implementation of the VM. The MACRA sunsets the VM, ending it after CY 2018 and establishing certain aspects of the VM as part of the resource use component of MIPS in CY 2019.

C. Overview of Section 101 of the MACRA

Section 101 of the MACRA amended sections 1848(d) and (f) of the Act to repeal the SGR formula for updating Medicare PFS payment rates and substituted a series of specified annual update percentages. Section 101 goes on to establish a new methodology that ties annual PFS payment adjustments to value for MIPS eligible clinicians. Section 101 also creates an incentive program to encourage participation by eligible clinicians in Advanced APMs.

Section 1848(q) of the Act, as added by section 101(c) of the MACRA, requires establishment of the MIPS, applicable beginning with payments for items and services furnished on or after January 1, 2019, under which the Secretary is required to: (1) Develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for a performance period for a year; (2) using the methodology, provide a CPS for each MIPS eligible clinician for each performance period; and (3) use the CPS of the MIPS eligible clinician for a performance period for a year to determine and apply a MIPS adjustment factor (and, as applicable, an additional MIPS adjustment factor) to the MIPS eligible clinician for the year. Under section 1848(q)(2)(A) of the Act, a MIPS eligible clinician's CPS is determined using four performance categories: (1) Quality; (2) resource use; (3) CPIA; and (4) advancing care information. Section 1848(q)(10) of the Act requires the Secretary to consult with stakeholders (through a request for information (RFI) or other appropriate means) in carrying out the MIPS, including for the identification of measures and activities for each of the four performance categories under the MIPS, the methodology to assess each MIPS eligible clinician's total performance to determine their MIPS CPS, the methodology to specify the MIPS adjustment factor for each MIPS eligible clinician for a year, and the use of QCDRs for purposes of the MIPS.

Section 1848(q)(11) of the Act, as added by section 101(c) of the MACRA, provides for technical assistance to MIPS eligible clinicians in small practices, rural areas, and practices located in geographic health professional shortage areas (HPSAs). In general, the section requires the Secretary to enter into contracts or agreements with appropriate entities (such as quality improvement organizations, regional extension centers (as described in section 3012(c) of the Public Health Service (PHS) Act), or regional health collaboratives) (such as those identified in section 1115A of the Act) to offer guidance and assistance to MIPS eligible clinicians in practices of 15 or fewer eligible clinicians. Priority is to be given to such practices located in rural areas which we propose to define at § 414.1305 to include clinicians in counties designated as Micropolitan or Non-Core Based Statistical Areas (CBSAs), using HRSA's 2014-2015 Area Health Resource File (http://datawarehouse.hrsa.gov/​data/​datadownload/​ahrfdownload.aspx), HPSAs (as designated under section 332(a)(1)(A) of the PHS Act), medically underserved areas (MUAs), and practices with low composite scores, for the MIPS performance categories or in transitioning to the implementation of, Start Printed Page 28169and participation in, an APM. Details regarding the technical assistance program are outside the scope of this proposed rule, and will be addressed in separate guidance.

Section 101(e) of the MACRA encourages participation in APMs by eligible clinicians and other eligible clinicians, and promotes the development of PFPMs by creating the PTAC. Specifically, this section: (1) Creates a payment incentive that applies to eligible clinicians from 2019 through 2024 who are Qualifying APM Participants (QPs) during the respective performance years, and provides for a higher fee schedule update for eligible clinicians who are QPs for a year beginning in 2026; (2) requires the establishment of a process for stakeholders to propose PFPMs to an independent PTAC that will review, comment on, and provide recommendations to the Secretary on the proposed PFPMs; and (3) requires CMS to establish criteria for PFPMs for use by the PTAC in making comments and recommendations to the Secretary. Additionally, section 101(c)(1) of the MACRA exempts QPs from payment adjustments under MIPS.

D. Stakeholder Input

In developing this proposed rule, in accordance with the law, we have sought feedback from stakeholders throughout the process such as in the 2016 Medicare PFS Proposed Rule; the Request for Information Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models (hereafter referred to as the MIPS and APMs RFI); listening sessions; conversations with a wide number of stakeholders; and conversations with tribes and tribal officials through CMS' Tribal Technical Advisory Group. In addition, we note that the National Indian Health Board has requested an opportunity for consultation with CMS, as well as that we coordinate its standards with the Indian Health Service. Through the MIPS and APMs RFI published in the Federal Register on October 1, 2015 (80 FR 59102, 59102-59113), the Secretary of Health and Human Services (the Secretary) solicited comments regarding implementation of certain aspects of the MIPS and broadly sought public comments on the topics in section 101 of the MACRA, including the incentive payments for participation in APMs and increasing transparency of PFPMs. We received a high number of public comments in response to the MIPS and APMs RFI from a broad range of sources including professional associations and societies, physician practices, hospitals, patient groups, and health IT vendors.

We appreciate the high level of interest expressed by commenters and acknowledge their valued input throughout this proposed rule, providing summaries of RFI comments in relevant sections of this rule. In general, commenters supported the passage of regulations implementing the MACRA and maintain optimism as we move from fee-for-service Medicare payment towards an enhanced focus on the quality and value of care. Public support for the MACRA focuses on the potential of a value-based program to provide enough flexibility to be applied meaningfully to physician practices and patient quality of care. Commenters cautioned us to avoid elements of prior reporting programs that have been perceived as too focused on the volume of measures reported rather than measure relevance and impact on treatment. Commenters also requested that we avoid implementing additional requirements on top of the fee-for-service system, which would increase the reporting and compliance burden for eligible clinicians. Commenters believe the underlying goal in establishing the MACRA should be to create a new program that combines a limited (yet meaningful) set of requirements with choices for health care providers on how to meet those requirements. Commenters requested that there be broad opportunities to participate in APMs and the development of new Advanced APMs, and that resources be made available to assist them in moving towards participation in APMs if they do not already participate. Commenters expressed eagerness to participate in Advanced APMs and to be a part of transforming care.

Once again, we thank stakeholders for their considered responses through various venues including comments to the MIPS and APMs RFI. We intend to continue open communication with stakeholders (including consultation with tribes and tribal officials) on an ongoing basis, and we look forward to comments on the policies proposed in this rule.

II. Provisions of the Proposed Regulations

A. Establishing MIPS and the APM Incentive

Section 1848(q) of the Act, as added by section 101(c) of the MACRA, requires establishment of the MIPS (see section I.C. of this proposed rule for additional background information). Section 101(e) of the MACRA promotes the development of, and participation in, APMs for eligible clinicians (see section I.C. of this proposed rule for additional background information). Further information will be provided in future rulemaking.

B. Program Principles and Goals

Through the MACRA amendments, we believe the Congress sets broad goals to be accomplished intended to improve care and health outcomes for every American. More specifically, our goal with the Quality Payment Program is to continue to support health care quality, efficiency, and patient safety. MIPS promotes better care, healthier people, and smarter spending by evaluating MIPS eligible clinicians using a CPS that incorporates MIPS eligible clinicians' performance on quality, resource use, clinical practice improvement activities, and advancing care information. Under the incentives for participation in Advanced APMs, our goals, described in greater detail in section II.F. of this proposed rule, are to expand the opportunities for participation in APMs, maximize participation in current and future Advanced APMs, create clear and attainable standards for incentives, promote the continued flexibility in the design of APMs, and support multi-payer initiatives across the health care market. The Quality Payment Program will encourage more MIPS eligible clinicians to participate in Advanced APMs, which link quality and value to payment. The APM Incentive Payment for eligible clinicians who qualify as QPs will only be available through Advanced APMs, but it is a powerful incentive to increase participation in those APMs. MIPS eligible clinicians participating in APMs (who do not qualify as QPs) will receive favorable scoring under certain MIPS categories.

Our strategic goals in developing the Quality Payment Program include: (1) Design a patient-centered approach to program development that leads to better, smarter, and healthier care; (2) develop a program that is meaningful, understandable, and flexible for participating clinicians; (3) design incentives that drive delivery system reform principles and participation in APMs; and (4) ensure close attention to CMS' excellence in implementation, effective communication with stakeholders and operational feasibility.Start Printed Page 28170

C. Changes to Existing Programs

1. Sunsetting of Current Payment Adjustment Programs

Section 101(b) of the MACRA calls for the sunsetting of payment adjustments under three existing programs for Medicare enrolled physicians and other practitioners:

The PQRS that incentivizes EPs to report on quality measures;

The VM that provides for budget neutral, differential payment adjustment for EPs in physician groups and solo practices based on quality of care compared to cost; and

The Medicare EHR Incentive Program for EPs that entails meeting certain requirements for the use of certified EHR technology.

Accordingly, we propose to revise certain regulations associated with these programs. We are not proposing to delete these regulations entirely, as the final payment adjustments under these programs will not occur until the end of 2018. For PQRS, we propose to revise § 414.90(e) introductory text and § 414.90(e)(1)(ii) to continue payment adjustments through 2018.

Similarly, we are proposing to amend the regulation text at § 495.102(d) to remove references to the payment adjustment percentage for years after the 2018 payment adjustment year and add a terminal limit of the 2018 payment adjustment year.

We are not proposing changes to 42 CFR part 414 subpart N—Value-Based Payment Modifier Under the PFS (§ 414.1200-1285), at this time. These regulations are already limited to certain years.

We are proposing to require EPs, eligible hospitals, and CAHs to attest (as part of their demonstration of meaningful use under the Medicare and Medicaid EHR Incentive Programs) that they have cooperated with the surveillance of certified EHR technology under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E. Similarly, we are proposing to require such an attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM Scoring Standard, as discussed in section II.E.5.h of this proposed rule.

On October 16, 2015, ONC published the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule (“2015 Edition final rule”). The final rule made changes to the ONC Health IT Certification Program that strengthen the testing, certification, and surveillance of health IT. In addition, the final rule clarified and expanded the responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) with respect to the surveillance of certified EHR technology and other health IT certified under the ONC Health IT Certification Program, including requirements for ONC-ACBs to conduct more frequent and more rigorous surveillance of certified technology and capabilities “in the field” (80 FR 62707). The purpose of in-the-field surveillance is to provide greater assurance that health IT meets certification requirements not only in a controlled testing environment but also when used by health care providers in actual production environments (80 FR 62707).

In addition to these changes, on March 2, 2016, ONC published the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule, which would expand ONC's role to strengthen oversight under the ONC Health IT Certification Program by providing a means for ONC to directly review and evaluate the performance of certified health IT in certain circumstances, such as in response to potential systemic or widespread issues, or in response to problems or issues that could pose a risk to public health or safety, compromise the security or privacy of patients' health information, or give rise to other exigencies (81 FR 11055).

These efforts to strengthen surveillance and other oversight of certified health IT, including through expanded in-the-field surveillance and ONC direct review of technology and capabilities, are critical to the success of HHS programs and initiatives that require the use of certified health IT to improve health care quality and the efficient delivery of care. With respect to the use of certified EHR technology under the Medicare and Medicaid EHR Incentive Programs and the MIPS Program, effective surveillance and oversight is fundamental to providing basic confidence that such technology consistently meets applicable standards, implementation specifications, and certification criteria adopted by the Secretary when it is used by eligible clinicians, EPs, eligible hospitals, and CAHs, as well as by other persons with whom eligible clinicians, EPs, eligible hospitals, and CAHs need to exchange electronic health information to comply with program requirements. The need to ensure that technology consistently meets applicable standards, implementation specifications, and certification criteria is important both at the time it is certified and on an ongoing basis when it is implemented and used in the field by eligible clinicians, EPs, eligible hospitals, and CAHs in order to meet objectives and measures under the Medicare and Medicaid EHR Incentive Program or MIPS. Efforts to strengthen surveillance and oversight of certified EHR technology in the field will become even more important as the types and capabilities of certified EHR technology continue to evolve and with the onset of Stage 3 of the Medicare and Medicaid EHR Incentive Programs and MIPS, which include heightened requirements for sharing electronic health information with other providers and with patients using a broad range of certified EHR technology and other health IT.[3]
Finally, we note that effective surveillance and oversight of certified EHR technology is necessary if eligible clinicians, EPs, eligible hospitals, and CAHs are to be able to rely on certifications issued under the ONC Health IT Certification Program as the basis for selecting appropriate technologies and capabilities that support the use of certified EHR technology while avoiding potential implementation and performance issues.

For all of these reasons, the effective surveillance and oversight of certified health IT, and certified EHR technology in particular, is necessary to enable eligible clinicians, EPs, eligible hospitals, and CAHs to demonstrate that they are using certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act. Yet as ONC observed in the 2015 Edition final rule, such surveillance and oversight will not be effective unless EPs, eligible hospitals, and CAHs are actively Start Printed Page 28171engaged and cooperate with the authorized surveillance and oversight of their technology, including by granting access to and assisting ONC and ONC-ACBs to observe the performance of production systems (80 FR 62716).

Accordingly, we are proposing that as part of demonstrating that it is using certified EHR technology in a meaningful manner, an eligible clinician, EP, eligible hospital, or CAH must demonstrate its cooperation with these authorized surveillance and oversight activities. We are proposing to revise the definition of a meaningful EHR user at § 495.4, as well as the attestation requirements at § 495.40(a)(2)(i)(H) and § 495.40(b)(2)(i)(H) to require EPs, eligible hospitals, and CAHs to attest their cooperation with certain authorized health IT surveillance and direct review activities, described in more detail in this section of the rule, as part of demonstrating meaningful use under the Medicare and Medicaid EHR Incentive Programs. Similarly, we are proposing to include an identical attestation requirement in the submission requirements for eligible clinicians under the advancing care information performance category proposed at § 414.1375.

We propose that eligible clinicians, EPs, eligible hospitals, and CAHs would be required to attest that they have cooperated in good faith with the surveillance and ONC direct review of their health IT certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT. Under the terms of the attestation, such cooperation would include responding in a timely manner and in good faith to requests for information (for example, telephone inquiries, written surveys) about the performance of the certified EHR technology capabilities in use by the provider in the field. The provider's cooperation would also include accommodating requests (from ONC-Authorized Certification Bodies or from ONC) for access to the provider's certified EHR technology (and data stored in such certified EHR technology) as deployed by the provider in its production environment, for the purpose of carrying out authorized surveillance or direct review, and to demonstrate capabilities and other aspects of the technology that are the focus of such efforts, to the extent that doing so would not compromise patient care or be unduly burdensome for the eligible clinician, EP, eligible hospital, or CAH.

We understand that cooperating with in-the-field surveillance may require prioritizing limited time and other resources. We note that ONC has established safeguards to minimize the burden of surveillance on eligible clinicians, EPs, eligible hospitals, and CAHs. In conducting randomized surveillance, ONC-ACBs must use consistent, objective, valid, and reliable methods to select the locations at which the surveillance will be performed (80 FR 62715). ONC-ACBs may also use appropriate sampling methodologies to minimize disruption to any individual provider or class of providers and to maximize the value and impact of surveillance activities for all providers and stakeholders (80 FR 62715). Moreover, if an ONC-ACB makes a good faith effort but is unable to complete in-the-field surveillance at a particular location, it may exclude the location and substitute a different location for surveillance (80 FR 62716).

In addition, we note that ONC has clarified, in consultation with the Office for Civil Rights, that ONC-ACBs engaging in authorized surveillance of certified EHR technology under the ONC Health IT Certification Program meet the definition of a “health oversight agency” in the HIPAA Privacy Rule (45 CFR 164.501), and as such a health care provider is permitted to disclose protected health information (PHI) (without patient authorization and without a business associate agreement) to an ONC-ACB during the limited time and as necessary for the ONC-ACB to perform the required on-site surveillance of the certified EHR technology (45 CFR 164.512(d)(1)(iii)) (80 FR 62716).[4]

For the foregoing reasons, we believe this proposal will support the surveillance and oversight of certified health IT, as necessary to support meaningful use of CEHRT for all eligible clinicians under the MIPS program, as well as EPs, eligible hospitals and CAHs under the Medicare and Medicaid EHR Incentive Programs, while ensuring that such surveillance or review does not create unnecessary or unreasonable burdens for health care providers or patients. We request public comment on this proposal.

b. Support for Health Information Exchange and the Prevention of Information Blocking

To prevent actions that block the exchange of information, section 106(b)(2)(A) of the MACRA amended section 1848(o)(2)(A)(ii) of the Act to require that, to be a meaningful EHR user, an EP must demonstrate that he or she has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology. Section 106(b)(2)(B) of MACRA made corresponding amendments to section 1886(n)(3)(A)(ii) of the Act for eligible hospitals and, by extension, under section 1814(l)(3) of the Act for CAHs. Sections 106(b)(2)(A) and (B) of the MACRA provide that the manner of this demonstration is to be through a process specified by the Secretary, such as the use of an attestation. Section 106(b)(2)(C) of the MACRA states that the demonstration requirements in these amendments shall apply to meaningful EHR users as of the date that is 1 year after the date of enactment, which would be April 16, 2016.

On December 16, 2014, in an explanatory statement accompanying the Consolidated and Further Continuing Appropriations Act,[5]
Congress urged ONC to take steps to decertify products that proactively block the sharing of information because those practices frustrate congressional intent, devalue taxpayer investments in certified EHR technology, and make certified EHR technology less valuable and more burdensome for eligible hospitals and eligible health care providers to use.[6]
Congress also asked for a detailed report on health information blocking, which ONC delivered on April 10, 2015. In the report, and based on the available evidence and its own experience, ONC found that some persons and entities—including some health care providers—are knowingly and unreasonably interfering with the exchange or use of electronic health information in ways that limit its availability and use to improve health and health care.[7]

Following these activities, on April 16, 2015, the MACRA was enacted, including section 106(b)(2), which amended sections 1848(o)(2)(A)(ii) and 1886(n)(3)(A)(ii) of the Act, as discussed in this section of the rule. Prior to these amendments, to be treated as a meaningful EHR user, an EP, eligible hospital, or CAH had to demonstrate to Start Printed Page 28172the satisfaction of the Secretary that its certified EHR technology was connected during the relevant EHR reporting period in a manner that provided, in accordance with law and standards applicable to the exchange of information, for the electronic exchange of health information to improve the quality of health care, such as promoting care coordination. As amended, respectively, by sections 106(b)(2)(A) and (B) of the MACRA, sections 1848(o)(2)(A)(ii) and 1886(n)(3)(A)(ii) of the Act now require that, in addition to demonstrating such connectivity, an eligible clinician, EP, eligible hospital, or CAH must also demonstrate that it did not knowingly and willfully take action to limit or restrict the compatibility or interoperability of the certified EHR technology.

We believe that, at a minimum, such a demonstration would need to provide substantial assurance not only that the certified EHR technology was connected in accordance with applicable standards during the relevant EHR reporting period, but that the eligible clinician, EP, eligible hospital, or CAH acted in good faith to implement and use the certified EHR technology in a manner that supported and did not interfere with the electronic exchange of health information among health care providers and with patients to improve quality and promote care coordination. Accordingly, we are proposing that such a demonstration be made through an attestation comprising three statements related to health information exchange and information blocking, which are set forth in our proposal in this rule. We are proposing to revise the definition of a meaningful EHR user at § 495.4 and the attestation requirements at § 495.40(a)(2)(i)(I) and § 495.40(b)(2)(i)(I) to provide that, for attestations submitted on or after April 16, 2016, an EP, eligible hospital, or CAH under the Medicare and Medicaid EHR Incentive Programs must attest to this three-part attestation. For the same reasons stated in this section of the rule, we are also proposing to require such an attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM Scoring Standard, as discussed in section II.E.5.h of this proposed rule. As noted in this section, the attestation we are proposing would consist of three statements related to health information exchange and information blocking. First, the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology.

Second, the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times: connected in accordance with applicable law; compliant with all standards applicable to the exchange of information, including the standards, implementation specifications, and certification criteria adopted at 45 CFR part 170; implemented in a manner that allowed for timely access by patients to their electronic health information; (including the ability to view, download, and transmit this information) and implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers (as defined by 42 U.S.C. 300jj(3)), including unaffiliated providers, and with disparate certified EHR technology and vendors.

Third, the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor's affiliation or technology vendor. We invite public comment on this proposal, including whether the foregoing statements could provide the Secretary with adequate assurances that an eligible clinician, EP, eligible hospital, or CAH has complied with the statutory requirements for information exchange. We also encourage public comment on whether there are additional facts or circumstances to which eligible clinicians, EPs, eligible hospitals, or CAHs should be required to attest, or whether there is additional information that they should be required to report.

D. Definitions

At § 414.1305, subpart O, we are proposing definitions for the following terms:

Additional performance threshold.

Advanced Alternative Payment Model (Advanced APM).

Advanced APM Entity.

Affiliated practitioner.

Alternative Payment Model (APM).

APM Entity.

APM Entity group.

APM Incentive Payment.

Attestation.

Attributed beneficiary.

Attribution-eligible beneficiary.

Certified Electronic Health Record Technology (CEHRT).

Clinical Practice Improvement Activity (CPIA).

CMS-approved survey vendor.

CMS Web Interface.

Composite performance score (CPS).

Covered professional services.

Eligible clinician.

Episode payment model.

Estimated aggregate payment amounts.

Group.

Health professional shortage areas (HPSA).

High priority measure.

Hospital-based MIPS eligible clinician.

Incentive payment base period.

Low-volume threshold.

Meaningful EHR user for MIPS.

Measure benchmark.

Medicaid APM.

Medical Home Model.

Medicaid Medical Home Model.

Merit-Based Incentive Payment System (MIPS).

MIPS APM.

MIPS Payment Year.

MIPS eligible clinician.

MIPS payment year.

New Medicare-Enrolled MIPS eligible clinician.

Non-patient-facing MIPS eligible clinician.

Other Payer Advanced APM.

Partial Qualifying APM Participant (Partial QP).

Partial QP patient count threshold.

Partial QP payment amount threshold.

Participation List.

Performance category score.

Performance standards.

Performance threshold.

Qualified Clinical Data Registry (QCDR).

Qualified registry.

QP patient count threshold.

QP payment amount threshold.

QP Performance Period.

Qualifying APM Participant (QP).

Rural areas.

Small practices.

Threshold Score.

Topped out measure.

Some of these terms are new in conjunction with MIPS and APMs, while others are used in existing CMS programs. For the new proposed terms and definitions, we note that some of Start Printed Page 28173them have been developed alongside proposed policies of this regulation while others are defined by statute. Specifically, the following terms and definitions were established by the MACRA: APM, CPIA, Eligible Alternative Payment Entity (which we have termed Advanced APM Entity), Eligible professional or EP (which we have termed eligible clinician), MIPS Eligible professional or MIPS EP (which we have termed MIPS eligible clinicians), Qualifying APM Participant, and Partial Qualifying APM Participant.

We invite public comments on all of these proposed terms and definitions, and discuss most of them in detail in relevant sections of this preamble.

E. MIPS Program Details

1. MIPS Eligible Clinicians

We believe a successful MIPS program fully equips clinicians identified as MIPS eligible clinicians with the tools and incentives to focus on improving health care quality, efficiency, and patient safety for all their patients. Under MIPS, MIPS eligible clinicians are incentivized to engage in proven improvement measures and activities that impact patient health and safety and are relevant for their patient population. One of our strategic goals in developing the MIPS program is to advance a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is by minimizing MIPS eligible clinicians' burden. We have made an effort to focus on policies that remove as much administrative burden as possible from MIPS eligible clinicians and their practices while still providing meaningful incentives for high-quality, efficient care. In addition, we hope to balance practice diversity with flexibility to address varied MIPS eligible clinicians' practices. Examples of this flexibility include special consideration for non-patient-facing MIPS eligible clinicians, an exclusion from MIPS for eligible clinicians who do not exceed the low-volume threshold, and other proposals discussed below.

a. Definition of a MIPS Eligible Clinician

Section 1848(q)(1)(C)(i) of the Act, as added by section 101(c)(1) of the MACRA, outlines the general definition of a MIPS eligible clinician for the MIPS program. Specifically, for the first and second year for which MIPS applies to payments (and the performance period for such years) a MIPS eligible clinician is defined as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. The statute also provides flexibility to specify additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) as MIPS eligible clinicians in the third and subsequent years of MIPS. As discussed in section II.E.3. of this proposed rule, section 1848(q)(1)(C)(ii) and (v) of the Act specifies several exclusions from the definition of a MIPS eligible clinician. In addition, section 1848(q)(1)(A) of the Act requires the Secretary to permit any eligible clinician (as defined in section 1848(k)(3)(B) of the Act) who is not a MIPS eligible clinician the option to volunteer to report on applicable measures and activities under MIPS. Section 1848(q)(1)(C)(vi) of the Act clarifies that a MIPS adjustment factor (or additional MIPS adjustment factor) will not be applied to an individual who is not a MIPS eligible clinician for a year, even if such individual voluntarily reports measures under MIPS.

To implement the MIPS program we must first establish and define a MIPS eligible clinician in accordance with the statutory definition. We propose to define a MIPS eligible clinician at § 414.1305 as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. In addition, we propose that Qualifying APM Participants, Partial Qualifying APM Participants who do not report data under MIPS, low-volume threshold eligible clinicians, and new Medicare-enrolled eligible clinicians as defined at § 414.1305 would be excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act. We intend to consider using our authority under section 1848(q)(1)(C)(i)(II) of the Act to expand the definition of MIPS eligible clinician to include additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) through rulemaking in future years.

In addition, in accordance with section 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we propose to allow eligible clinicians who are not MIPS eligible clinicians as defined at proposed § 414.1305 the option to voluntarily report measures and activities for MIPS. We propose at § 414.1310(d) that those eligible clinicians who are not MIPS eligible clinicians, but who voluntarily report on applicable measures and activities specified under MIPS, would not receive an adjustment under MIPS; however, they will have the opportunity to gain experience in the MIPS program. We are particularly interested in public comment regarding the feasibility and advisability of voluntary reporting in the MIPS program for entities such as Rural Health Clinics (RHCs) and/or Federally Qualified Health Centers (FQHCs), including comments regarding the specific technical issues associated with reporting that are unique to these health care providers. We anticipate some eligible clinicians that will not be MIPS eligible clinicians during the first 2 years of MIPS, such as physical and occupational therapists, clinical social workers, and others that have been reporting quality measures under the PQRS for a number of years, will want to have the ability to continue to report and gain experience under MIPS. We request comments on these proposals.

b. Non-Patient-Facing MIPS Eligible Clinicians

Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in specifying measures and activities for a performance category, to give consideration to the circumstances of professional types (or subcategories of those types determined by practice characteristics) who typically furnish services that do not involve face-to-face interaction with a patient. To the extent feasible and appropriate, the Secretary may take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such non-patient-facing MIPS eligible clinicians. In carrying out these provisions, we are required to consult with non-patient-facing MIPS eligible clinicians.

In addition, section 1848(q)(5)(F) of the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient-facing MIPS eligible clinicians will not have sufficient measures and activities applicable and available to report under the performance categories under MIPS. We refer readers to section II.E.6. of this proposed rule to discuss how we address performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given category.Start Printed Page 28174

To establish policies surrounding non-patient-facing MIPS eligible clinicians, we must first define the term “non-patient-facing.” Currently, the PQRS, VM, and Medicare EHR Incentive Program include two existing policies for considering whether an EP is providing patient-facing services. To determine, for purposes of PQRS, whether an EP had a “face-to-face” encounter with Medicare patients, we assess whether the EP billed for services under the PFS that are associated with face-to-face encounters, such as whether an EP billed general office visit codes, outpatient visits, and surgical procedures. Under PQRS, if an EP bills for at least one service under the PFS during the performance period that is associated with face-to-face encounters and reports quality measures via claims or registries, then the EP is required to report at least one “cross-cutting” measure. EPs who do not meet these criteria are not required to report a cross-cutting measure. For the purposes of PQRS, telehealth services have not historically been included in the definition of face-to-face encounters. For more information, please see the CY 2016 PFS final rule for these discussions (80 FR 71140).

In the Stage 2 final rule (77 FR 54098 through 54099), the Medicare EHR Incentive Program established a significant hardship exception from the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act for EPs that lack face-to-face interactions with patients and those who lack the need to follow-up with patients. EPs with a primary specialty of anesthesiology, pathology or radiology listed in the Provider Enrollment, Chain, and Ownership System (PECOS) as of 6 months prior to the first day of the payment adjustment year automatically receive this hardship exemption (77 FR 54100). Codes associated with these specialties include 05 Anesthesiology, 22 Pathology, 30 Diagnostic Radiology, 36 Nuclear Medicine, 94 Interventional Radiology. EPs with a different specialty are also able to request this hardship exception through the hardship application process. However, telehealth services could be counted by EPs who choose to include these services within the definition of “seen by the EP” for the purposes of calculating patient encounters with the EHR Incentive Program (77 FR 53982).

In the MIPS and APMs RFI, we sought comments on MIPS eligible clinicians that should be considered non-patient-facing MIPS eligible clinicians and the criteria we should use to identify these MIPS eligible clinicians. Commenters were split when it came to defining and identifying non-patient-facing MIPS eligible clinicians. Many took a specialty-driven approach. Commenters generally did not support use of enrollment specialty codes alone, which is the approach used by the Medicare EHR Incentive Program. Commenters indicated that these codes do not necessarily delineate between the same specialists who may or may not have patient-facing interaction. One example is cardiologists who specialize in cardiovascular imaging which is also coded as cardiology. On the other hand, as one commenter mentioned, physicians with enrollment specialty codes other than “cardiology” (for example, internal medicine) may perform cardiovascular imaging services. Therefore, using the enrollment specialty code for cardiology to identify clinicians who typically do not provide patient-facing services would be both over-inclusive and under-inclusive. Other commenters identified specialty types that they believe should be considered non-patient-facing MIPS eligible clinicians. Specific specialty types included radiologists, anesthesiologists, nuclear cardiology or nuclear medicine physicians, and pathologists. Others pointed out that certain MIPS eligible clinicians may be primarily non-patient-facing MIPS eligible clinicians even though they practice within a traditionally patient-facing specialty. The MIPS and APMs RFI comments and listening sessions with medical societies representing non-patient-facing MIPS eligible clinicians specified radiology/imaging, anesthesiology, nuclear cardiology and oncology, and pathology as inclusive of non-patient-facing MIPS eligible clinicians. Commenters noted that roles within specific types of specialties may need to be further delineated between patient-facing and non-patient-facing MIPS eligible clinicians. An illustrative list of specific types of clinicians within the non-patient-facing spectrum include:

Pathologists who may be primarily dedicated to working with local hospitals to identify early indicators related to evolving infectious diseases;

Radiologists who primarily provide consultative support back to a referring physician or provide image interpretation and diagnosis versus therapy;

Nuclear medicine physicians who play an indirect role in patient care, for example as a consultant to another physician in proper dose administration; or

Some commenters believed that MIPS eligible clinicians should be defined as non-patient-facing MIPS eligible clinicians based on whether their billing indicates they provide face-to-face services. Commenters indicated that the use of specific HCPCS codes in combination with enrollment specialty codes, may be a more appropriate way to identify MIPS eligible clinicians that have no patient interaction.

After reviewing current policies, we propose to define a non-patient-facing MIPS eligible clinicians for MIPS at § 414.1305 as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters during a performance period. We consider a patient-facing encounter as an instance in which the MIPS eligible clinician or group billed for services such as general office visits, outpatient visits, and surgical procedure codes under the PFS. We intend to publish the proposed list of patient-facing encounter codes on a CMS Web site similar to the way we currently publish the list of face-to-face encounter codes for PQRS. This proposal differs from the current PQRS policy in two ways. First, it creates a minimum threshold for the quantity of patient-facing encounters that MIPS eligible clinicians or groups would need to furnish to be considered patient-facing, rather than classifying MIPS eligible clinicians as patient-facing based on a single patient-facing encounter. Second, this proposal includes telehealth services in the definition of patient-facing encounters.

We believe that setting the non-patient-facing MIPS eligible clinician threshold for individual MIPS eligible clinician or group at 25 or fewer billed patient-facing encounters during a performance period is appropriate. We selected this threshold based on an analysis of non-patient-facing HCPCS codes billed by MIPS eligible clinicians. Using these codes and this threshold we identified approximately one quarter of MIPS eligible clinicians as non-patient-facing before MIPS exclusions, such as low-volume and newly-enrolled eligible clinician policies, were applied. The majority of clinicians enrolled in Medicare with specialties such as anesthesiology, nuclear medicine, and pathology were identified as non-patient-facing in this analysis. The addition of telemedicine to the analysis did not affect the outcome, as it created a less than 0.01 percent change in MIPS eligible clinicians categorized as non-patient-facing.Start Printed Page 28175

Therefore, this proposed approach allows the definition of non-patient-facing MIPS eligible clinicians, to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient-facing, as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices. This definition is also consistent with the statutory requirement that refers to professional types who typically furnish services that do not involve patient-facing interaction with a patient.

We also propose to include telehealth services in the definition of patient-facing encounters. Various MIPS eligible clinicians use telehealth services as an innovative way to deliver care to beneficiaries and we believe these services, while not furnished in-person, should be recognized as patient-facing. In addition, Medicare eligible telehealth services substitute for an in-person encounter and meet other site requirements under the PFS as defined at § 410.78.

The proposed addition of the encounter threshold for patient-facing MIPS eligible clinicians should minimize concerns that a MIPS eligible clinician could be misclassified as patient-facing as a result of providing occasional telehealth services that do not represent the bulk of their practice. Finally, this proposed definition of a non-patient-facing MIPS eligible clinician for MIPS can be consistently used throughout the MIPS program to identify those MIPS eligible clinicians for whom certain proposed requirements for patient-facing MIPS eligible clinicians (such as reporting cross-cutting measures) may not be meaningful.

We weighed several options when considering the appropriate definition of non-patient-facing MIPS eligible clinicians for MIPS; and some options were similar to those we considered in implementing the Medicare EHR Incentive Program. One option we considered was basing the non-patient-facing MIPS eligible clinician's definition on a set percentage of patient-facing encounters, such as 5 to 10 percent, that is tied to the same list of patient-facing encounter codes discussed in this section of the proposed rule. Another option we considered was the identification of non-patient-facing MIPS eligible clinicians for MIPS only by specialty, which might be a simpler approach. However, we do not consider this approach sufficient for identifying all the possible non-patient-facing MIPS eligible clinicians, as some patient-facing MIPS eligible clinicians practice in multi-specialty practices with non-patient-facing MIPS eligible clinician's practices with different specialties. We would likely have had to develop a separate process to identify non-patient-facing MIPS eligible clinicians in other specialties, whereas maintaining a single definition that is aligned across performance categories is simpler. Many comments from the MIPS and APMs RFI discouraged use of enrollment specialty alone. Additionally, we believe our proposal would allow us to more accurately identify MIPS eligible clinicians who are non-patient-facing by applying a threshold to recognize that a MIPS eligible clinician who furnishes almost exclusively non-patient-facing services should be treated as a non-patient-facing MIPS eligible clinicians despite furnishing a small number of patient-facing services. We seek comment on these alternative approaches.

In the MIPS and APMs RFI, we also requested comments on what types of measures and/or CPIAs (new or from other payment systems) we should use to assess non-patient-facing MIPS eligible clinicians' performance and how we should apply the MIPS performance categories to non-patient-facing MIPS eligible clinicians. Commenters were split on these subjects. A number of commenters stated that non-patient-facing MIPS eligible clinicians should be exempt from specific performance categories under MIPS or should be exempt from MIPS as a whole. Commenters who did not favor exemptions generally suggested that we focus on process measures and work with specialty societies to develop new, more clinically relevant measures for non-patient-facing MIPS eligible clinicians.

We took these stakeholder comments into consideration. We note that section 1848(q)(2)(C)(iv) of the Act does not grant the Secretary discretion to exempt non-patient-facing MIPS eligible clinicians from a performance category entirely, but rather to apply to the extent feasible and appropriate alternative measures or activities that fulfill the goals of the applicable performance category. However, we have placed safeguards to ensure that MIPS eligible clinicians, including non-patient facing, that do not have sufficient alternative measures that are applicable and available in a performance category are scored appropriately. We propose to apply the Secretary's authority under section 1848(q)(5)(F) of the Act to reweight such performance categories score to zero if there is no performance category score or to lower the weight of the quality performance category score if there are not at least three scored measures. Please refer to section II.E.6.b.(2)(b) in this proposed rule for details on the reweighting proposals. Accordingly, we have proposed alternative requirements for non-patient-facing MIPS eligible clinicians across this proposed rule (see sections II.E.5.b. II.E.5.e. and II.E.5.f. of this proposed rule for more details). While non-patient-facing MIPS eligible clinicians will not be exempt from any performance category under MIPS, we believe these alternative requirements fulfill the goals of the applicable performance categories and are in line with the commenters' desire to ensure that non-patient-facing MIPS eligible clinicians are not placed at an unfair disadvantage under the new program. The requirements also build on prior program components in meaningful ways and are meant to help us appropriately assess and incentivize non-patient-facing MIPS eligible clinicians. We request comments on these proposals.

Section 1848(q)(6)(E) of the Act provides that the MIPS adjustment is applied to the amount otherwise paid under Part B for the items and services furnished by a MIPS eligible clinician during a year (beginning with 2019). In the case of MIPS eligible clinicians who practice in CAHs that bill under Method I (“Method I CAHs”), the MIPS adjustment would apply to payments made for items and services billed by MIPS eligible clinicians under the PFS, but it would not apply to the facility payment to the CAH itself. In the case of MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS adjustment would apply in the same manner as for MIPS eligible clinicians who bill for items and services in Method I CAHs.

Under section 1834(g)(2) of the Act, a Method II CAH bills and is paid for facility services at 101 percent of its reasonable costs and for professional services at 115 percent of such amounts as would otherwise be paid under this part if such services were not included in outpatient critical access hospital services. In the case of MIPS eligible clinicians who practice in Method II CAHs and have assigned their billing rights to the CAHs, those professional services would constitute “covered professional services” under section 1848(k)(3)(A) of the Act because they are furnished by an eligible clinician Start Printed Page 28176and payment is “based on” the PFS. Moreover, this is consistent with the precedent CMS has established by applying the PQRS and EHR-MU adjustments to Method II CAH payments. Therefore, we propose the MIPS adjustment does apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH. We request comments on this proposal.

As noted previously in this proposed rule, section 1848(q)(6)(E) of the Act provides that the MIPS adjustment is applied to the amount otherwise paid under Part B with respect to the items and services furnished by a MIPS eligible clinician during a year. Some eligible clinician s may not receive MIPS adjustments due to their billing methodologies. If a MIPS eligible clinician furnishes items and services in an RHC and/or FQHC and the RHC and/or FQHC bills for those items and services under the RHC's or FQHC's all-inclusive payment methodology, the MIPS adjustment would not apply to the facility payment to the RHC or FQHC itself. However, if a MIPS eligible clinician furnishes other items and services in an RHC and/or FQHC and bills for those items and services under the PFS, the MIPS adjustment would apply to payments made for items and services. Accordingly, the MIPS eligible clinician would need to meet the applicable MIPS reporting requirements to avoid a downward MIPS adjustment to payments made for items and services billed by the MIPS eligible clinician under the PFS. Therefore, we propose services rendered by an eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS and the data received would not be used to assess their performance for the purpose of the MIPS adjustment. We request comments on this proposal.

e. Group Practice (Group)

Section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for purposes of assessing performance in the quality performance category. In addition, it gives the Secretary the discretion to do so for the other three performance categories. Additionally, we will assess performance either for individual MIPS eligible clinicians or for groups. As discussed in section II.E.2.b of this proposed rule, we propose to define a group at § 414.1305 as a single Taxpayer Identification Number (TIN) with two or more MIPS eligible clinicians, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicare billing rights to the TIN. Also, as outlined in section II.E.2.c. of this proposed rule, we propose to define an APM Entity group at § 414.1305 identified by a unique APM participant identifier.

2. MIPS Eligible Clinician Identifier

To support MIPS eligible clinicians reporting to a single comprehensive and cohesive MIPS program, we need to align the technical reporting requirements from PQRS, VM, and EHR-MU into one program. This requires an appropriate MIPS eligible clinician identifier. We currently use a variety of identifiers to assess an individual eligible clinician or group under different programs. For example, under the PQRS for individual reporting, CMS uses a combination of TIN and NPI to assess eligibility and participation, where each unique TIN and NPI combination is treated as a distinct eligible clinician and is separately assessed for purposes of the program. Under the PQRS GPRO, eligibility and participation are assessed at the TIN level. Under the Medicare EHR Incentive Program, we utilize the NPI to assess eligibility and participation. And under the VM, performance and payment adjustments are assessed at the TIN level. Additionally, for APMs such as the Pioneer Accountable Care Organization (ACO) Model, we also assign a program-specific identifier (in the case of the Pioneer ACO Model, an ACO ID) to the organization(s), and associate that identifier with individual eligible clinicians who are, in turn, identified through a combination of a TIN and an NPI.

In the MIPS and APMs RFI, we sought comments on which specific identifier(s) should be used to identify a MIPS eligible clinician for purposes of determining eligibility, participation, and performance under the MIPS performance categories. In addition, we requested comments pertaining to what safeguards should be in place to ensure that MIPS eligible clinicians do not switch identifiers to avoid being considered “poor-performing” and comments on what safeguards should be in place to address any unintended consequences, if the MIPS eligible clinician identifier were a unique TIN/NPI combination, to ensure an appropriate assessment of the MIPS eligible clinician's performance. In the MIPS and APMs RFI, we sought comment on using a MIPS eligible clinician's TIN, NPI, or TIN/NPI combination as potential MIPS eligible clinician identifiers, or creating a unique MIPS eligible clinician identifier. The commenters did not demonstrate a consensus on a single best identifier.

Commenters favoring the use of the MIPS eligible clinician's TIN recommended that MIPS eligible clinicians should be associated with the TIN used for receiving payment from CMS claims. They further commented that this approach will deter MIPS eligible clinicians from “gaming” the system by switching to a higher performing group. Under this approach, commenters suggest that MIPS eligible clinicians who bill under more than one TIN can be assigned the performance and payment adjustment for the primary practice based upon majority of dollar amount of claims or encounters from the prior year.

Other commenters supported using unique TIN and NPI combinations to identify MIPS eligible clinicians. Commenters suggested many eligible clinicians are familiar with using TIN and NPI together from PQRS and other CMS programs. Commenters also noted this approach can calculate performance for multiple unique TIN/NPI combinations for those MIPS eligible clinicians who practice under more than one TIN. Commenters who supported the TIN/NPI also believe this approach enables greater accountability for individual MIPS eligible clinicians beyond what might be achieved when using TIN as an identifier and would provide a safeguard from MIPS eligible clinicians changing their identifier to avoid payment penalties.

Some commenters supported the use of only the NPI as the MIPS identifier. They believe this approach would best provide for individual accountability for quality in MIPS while minimizing potential confusion because providers do not generally change their NPI over time. Supporters of using the NPI only as the MIPS identifier also commented that this approach would be simplest for administrative purposes. These commenters also note the continuity inherent with the NPI would address the safeguard issue of providers Start Printed Page 28177attempting to change their identifier for MIPS performance purposes.

In the MIPS and APMs RFI, we also solicited feedback on the potential for creating a new MIPS identifier for the purposes of identifying MIPS eligible clinicians within the MIPS program. In response, many commenters indicated they would not support a new MIPS identifier. Commenters generally expressed concern that a new identifier for MIPS would only add to administrative burden, create confusion for MIPS eligible clinicians and increase reporting errors.

After reviewing the comments, we are not proposing to create a new MIPS eligible clinician identifier. However, we appreciate the various ways a MIPS eligible clinician may engage with MIPS, either individually or through a group. Therefore, we are proposing to use multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance. We also propose that the same identifier be used for all four performance categories; for example, if a group is submitting information collectively, then it must be measured collectively for all four MIPS performance categories: Quality, resource use, CPIA, and advancing care information. As discussed later in the CPS methodology section II.E.6. of this proposed rule, while we have multiple identifiers for participation and performance, we proposed to use a single identifier, TIN/NPI, for applying the payment adjustment, regardless of how the MIPS eligible clinician is assessed. Specifically, if the MIPS eligible clinician is identified for performance only using the TIN, when applying the payment adjustment we propose to use the TIN/NPI. We request comments on these proposals.

a. Individual Identifiers

We propose to use a combination of billing TIN/NPI as the identifier to assess performance of an individual MIPS eligible clinician. Similar to PQRS, each unique TIN/NPI combination would be considered a different MIPS eligible clinician, and MIPS performance would be assessed separately for each TIN under which an individual bills. While we considered using the NPI only, we believe TIN/NPI is a better approach for MIPS. Both TIN and NPI are needed for payment purposes and using a combination of billing TIN/NPI as the MIPS eligible clinician identifier allows us to match MIPS performance and payment adjustments with the appropriate practice, particularly for MIPS eligible clinicians that bill under more than one TIN. In addition, using TIN/NPI also provides the flexibility to allow individual MIPS eligible clinician and group reporting, as the group identifiers being proposed also include TIN as part of the identifier. We recognize that TIN/NPI is not a static identifier and can change if an individual MIPS eligible clinician changes practices and/or if a group merges with another between the performance period and payment adjustment period. Section II.E.5.h. of this proposed rule describes in more detail how we propose to match performance in cases where the TIN/NPI changes. We request comments on this proposal.

b. Group Identifiers for Performance

We propose the following way a MIPS eligible clinician may have their performance assessed as part of a group under MIPS. We propose to use a group's billing TIN to identify a group. This approach has been used as a group identifier for both PQRS and VM. The use of the TIN would significantly reduce the participation burden that could be experienced by large groups. Additionally, the utilization of the TIN benefits large and small practices by allowing such entities to submit performance data one time for their group and develop systems to improve performance. Groups that report on quality performance measures through certain data submission methods must register in order to participate in MIPS as described in section II.E.5.b. of this proposed rule.

We are proposing to codify the definition of a group at § 414.1305 as a group that would consist of a single TIN with two or more MIPS eligible clinicians (as identified by their individual NPI) who have reassigned their billing rights to the TIN. We request comments on this proposal.

c. APM Entity Group Identifier for Performance

We propose the following way to identify a group to support APMs (see section II.F.5.b. of this proposed rule). To ensure we have accurately captured all of the eligible clinicians identified as participants that are participating in the APM Entity, we propose that each eligible clinician who is a participant of an APM Entity would be identified by a unique APM participant identifier. The unique APM participant identifier would be a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). For example, an APM participant identifier could be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111.

We are proposing to codify the definition of an APM Entity group at § 414.1305 as an APM Entity identified by a unique APM participant identifier. We request comments on these proposals. See section II.E.5.h. of this rule for proposed policies regarding requirements for APM Entity groups under MIPS.

3. Exclusions

a. New Medicare-Enrolled Eligible Clinician

Section 1848(q)(1)(C)(v) of the Act provides that in the case of a professional who first becomes a Medicare-enrolled eligible clinician during the performance period for a year (and had not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier), that the eligible clinician will not be treated as a MIPS eligible clinician until the subsequent year and performance period for that year. In addition, section 1848(q)(1)(C)(vi) of the Act clarifies that individuals who are not deemed MIPS eligible clinicians for a year will not receive a MIPS adjustment factor (or additional MIPS adjustment factor). Accordingly, we propose at § 414.1305 that a new Medicare-enrolled eligible clinician be defined as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. These eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. As discussed in section II.E.4. of this proposed rule, we are proposing that the MIPS performance period would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS adjustment is applied. For example, an eligible clinician who newly enrolls in Medicare within PECOS in 2017 would not be required to participate in MIPS in 2017, and he or she would not receive a MIPS adjustment in 2019. The same eligible clinician would be required to participate in MIPS in 2018 and would Start Printed Page 28178receive a MIPS adjustment in 2020, and so forth. In addition, in the case of items and services furnished during a year by an individual who is not an MIPS eligible clinician, there will not be a MIPS adjustment factor (or additional MIPS adjustment factor) applied for that year. We also propose at § 414.1310(d) that in no case would a MIPS adjustment factor (or additional MIPS adjustment factor) apply to the items and services furnished by new Medicare-enrolled eligible clinicians.

Sections 1848(q)(1)(C)(ii)(I) and (II) of the Act provide that the definition of a MIPS eligible clinician does not include, for a year, an eligible clinician who is a Qualifying APM Participant (QP) (as defined in section 1833(z)(2) of the Act) or a Partial Qualifying APM Participant (Partial QP) (as defined in section 1848(q)(1)(C)(iii) of the Act) who does not report on the applicable measures and activities that are required under MIPS. Section II.F.5. of this proposed rule provides detailed information on the determination of QPs and Partial QPs.

We propose that the definition of a MIPS eligible clinician at § 414.1310 does not include qualifying APM participants (defined at § 414.1305) and Partial QPs defined at § 414.1305 who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period. Partial QPs will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS adjustments. Please refer to the section II.F.5.c. of this proposed rule where this election is discussed in greater detail. We request comments on this proposal.

c. Low-Volume Threshold

Section 1848(q)(1)(C)(ii)(III) of the Act provides that the definition of a MIPS eligible clinician does not include MIPS eligible clinicians who are below the low-volume threshold selected by the Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year. Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a low-volume threshold to apply for the purposes of this exclusion which may include one or more of the following: (1) The minimum number, as determined by the Secretary, of Part B-enrolled individuals who are treated by the MIPS eligible clinician for a particular performance period; (2) the minimum number, as determined by the Secretary, of items and services furnish to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the MIPS eligible clinician for a particular performance period.

We propose at § 414.1305 to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We believe this strategy is value-oriented as it retains as MIPS eligible clinicians those MIPS eligible clinicians who are treating relatively few beneficiaries, but engage in resource intensive specialties, or those treating many beneficiaries with relatively low-priced services. By requiring both criteria be met, we can meaningfully measure the performance and drive quality improvement across the broadest range of MIPS eligible clinician types and specialties. Conversely, it excludes MIPS eligible clinicians who do not have a substantial quantity of interactions with Medicare beneficiaries or furnish high cost services.

In developing this proposal we considered using items and services furnished to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period rather than patients but a review of the data reflected there were nominal differences between the two methods. We plan to monitor the proposed requirement and anticipate that the specific thresholds will evolve over time. We request comments on this proposal including alternative patient threshold, case thresholds, and dollar values.

d. Group Reporting

(1) Background

As noted above, section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for the purpose of assessing performance in the quality category and give the Secretary the discretion to do so for the other performance categories. The process established for purposes of MIPS must, to the extent practicable, reflect the range of items and services furnished by the MIPS eligible clinicians in the group. We believe this means that the process established for purposes of MIPS should, to the extent practicable, encompass elements that enable MIPS eligible clinicians in a group to meet reporting requirements that reflect the range of items and services furnished by the MIPS eligible clinicians in the group. At § 414.1310(e) we propose requirements for groups. For purposes of section 1848(q)(1)(D) of the Act, at § 414.1310(e)(1) we propose the following way for individual MIPS eligible clinicians to have their performance assessed as a group: As part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN (as discussed further in section II.E.1.f. of this proposed rule).

In order to have its performance assessed as a group, at § 414.1310(e)(2) we propose a group must meet the proposed definition of a group at all times during the performance period for the MIPS payment year. Additionally, at § 414.1310(e)(3) we propose in order to have their performance assessed as a group, individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN. At § 414.1310(e)(3), we propose a group that elects to have its performance assessed as a group would be assessed as a group across all four MIPS performance categories. For example, if a group submits data for the quality performance category as a group, CMS would assess them as a group for the remaining three performance categories. We solicit public comments on the proposal regarding how groups will be assessed under MIPS.

(2) Registration

Under the PQRS, groups are required to complete a registration process to participate in PQRS as a group. During the implementation and administration of PQRS, we received feedback from stakeholders regarding the registration process for the various methods available for data submission. Stakeholders indicated that the registration process was burdensome and confusing. Additionally, we discovered that during the registration process when groups are required to select their group submission mechanism, groups sometimes selected the option not applicable to their group, which has created issues surrounding the mismatch of data. Unreconciled data mismatching can impact the quality of data. In order to address this issue, we are proposing to eliminate a registration process for groups submitting data using third party entities. When groups Start Printed Page 28179submit data utilizing third party entities, such as a qualified registry, health IT vendor, or QCDR, we are able to obtain group information from the third party entity and discern whether the data submitted represents group submission or individual submission once the data is submitted.

At § 414.1310(e)(5), we propose that a group must adhere to an election process established and required by CMS, as described below. We do not propose to require groups to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey for the quality performance category as described further in section II.E.5.b. of this proposed rule. For all other data submission methods, groups must work with appropriate third party entities to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission. In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, we propose that such groups must register by June 30 of the applicable 12-month performance period (that is, June 30, 2017, for performance periods occurring in 2017). For the criteria regarding group reporting applicable to the four MIPS performance categories, see section II.E.5.a. of this proposed rule.

e. Virtual Groups

(1) Implementation

Section 1848(q)(5)(I) of the Act establishes the use of voluntary virtual groups for certain assessment purposes. The statute requires the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect to form a virtual group with at least one other such individual MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians for a performance period of a year. As determined in statute, individual MIPS eligible clinicians and groups forming virtual groups are required to make such election prior to the start of the applicable performance period under MIPS and cannot change their election during the performance period. As discussed in section II.E.4. of this proposed rule, we are proposing that the performance period would be based on a calendar year.

As we assessed the timeline for the establishment and implementation of virtual groups and applicable election process and requirements for the first performance period under MIPS, we identified significant barriers regarding the development of a technological infrastructure required for successful implementation and the operationalization of such provisions that would negatively impact the execution of virtual groups as a conducive option for MIPS eligible clinicians or groups. The development of an electronic system before policies are finalized poses several risks, particularly relating to the impediments of completing and adequately testing the system before execution and assuring that any change in policy made during the rulemaking process are reflected in the system and operationalized accordingly. We believe that it would be exceedingly difficult to make a successful system to support the implementation of virtual groups and given these factors, such implementation would compromise not only the integrity of the system, but the intent of the policies.

Additionally, we recognize that it would be impossible for us to develop an entire infrastructure for electronic transactions pertaining to an election process, reporting of data, and performance measurement before the start of the performance period beginning on January 1, 2017. Moreover, the actual implementation timeframe would be more condensed given that the development, testing, and execution of such a system would need to be completed months in advance of the beginning of the performance period in order to provide MIPS eligible clinicians and groups with an election period.

During the implementation and ongoing functionality of other programs such as PQRS, Medicare EHR Incentive Program, and VM, we received feedback from stakeholders regarding issues they encountered when submitting reportable data for these programs. With virtual groups as a new option, we want to minimize potential issues for end-users and implement a system that encourages and enables MIPS eligible clinicians and groups to participate in a virtual group. A web-based registration process, which would simplify and streamline the process for participation, is our preferred approach. Given the aforementioned dynamics discussed in this section, implementation for the calendar year 2017 performance period is infeasible as a result of the insufficient timeframe to develop a web-based registration process. We have assessed alternative approaches for the first year only, such as an email registration process, but believe that there are limitations and potential risks for numerous errors, such as submitted information being incomplete or not in the required format. A manual verification process would cause a significant delay in verifying registration due to the lack of an automated system to ensure the accuracy of the type of information submitted that is required for registration. We believe that an email registration process could become cumbersome and a burden for groups to pursue participation in a virtual group. Implementation of a web-based registration system for calendar year 2018 would provide the necessary time to establish and implement an election process and requirements applicable to virtual groups, and enable proper system development and operations. We intend to implement virtual groups for the 2018 calendar year performance period and we intend to address all of the requirements pertaining to virtual groups in future rulemaking. We request comments on factors we should consider regarding the establishment and implementation of virtual groups.

(2) Election Process

Section 1848(q)(5)(I)(iii)(I) of the Act provides that the election process must occur prior to the performance period and may not be changed during the performance period. We propose to establish an election process that would end on June 30 of a calendar year preceding the applicable performance period. During the election process, we propose that individual MIPS eligible clinicians and groups electing to be a virtual group would be required to register in order to submit reportable data. Virtual groups would be assessed across all four MIPS performance categories. In future rulemaking, we intend to address all elements relating to the election process. We solicit public comments on this proposal. Future rulemaking will outline the criteria and requirements regarding the formation of virtual groups.

4. MIPS Performance Period

MIPS incorporates many of the requirements of several programs into a single, comprehensive program. This consolidation includes key policy goals as common themes across multiple categories such as quality improvement, patient and family engagement, and care coordination through interoperable health information exchange. However, each of these legacy programs included different eligibility requirements, reporting periods, and systems for Start Printed Page 28180providers seeking to participate. This means that we must balance potential impacts of changes to systems and technical requirements in order to successfully synchronize reporting, as noted in the discussion regarding the definition of a MIPS eligible clinician in section II.E.1.a. of this proposed rule. We must take operational feasibility, systems impacts, and education and outreach on participation requirements into account in developing technical requirements for participation. One area where this is particularly important is in the definition of a performance period.

MIPS applies to payments for items and services furnished on or after January 1, 2019. Section 1848(q)(4) of the Act requires the Secretary to establish a performance period (or periods) for a year (beginning with 2019). Such performance period (or periods) must begin and end prior to such year and be as close as possible to such year. In addition, section 1848(q)(7) of the Act provides that, not later than 30 days prior to January 1 of the applicable year, the Secretary must make available to each MIPS eligible clinician the MIPS adjustment (and, as applicable, the additional MIPS adjustment) applicable to the MIPS eligible clinician for items and services furnished by the MIPS eligible clinician during the year.

We considered various factors when developing the policy for the MIPS performance period. Stakeholders have stated that having a performance period as close to when payments are adjusted is beneficial, even if such period would be less than a year. We have also received feedback from stakeholders that they prefer having a 1 year performance period and have further suggested that the performance period start during the calendar year. For example, having the performance period occurring from July 1 through June 30. We additionally considered operational factors, such as that a 1 year performance period may be beneficial for all four performance categories because many measures and activities cannot be reported in a shorter time frame. We also considered that data submission activities and claims for items and services furnished during the 1 year performance period (which could be used for claims- or administrative claims-based quality or resource use measures) may not be fully processed until the following year.

These circumstances will require adequate lead time to collect performance data, assess performance, and compute the MIPS adjustment so the applicable MIPS adjustment can be made available to each MIPS eligible clinician at least 30 days prior to when the payment adjustment is applied each year. For 2019, these actions will occur during 2018. In other payment systems, we have used claims that are processed within a specified time period after the end of the performance period, such as 60 or 90 days, for assessment of performance and application of the payment adjustment. For MIPS, we propose at § 414.1325(g)(2) to use claims that are processed within 90 days, if operationally feasible, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. If we determine that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we would utilize a 60-day duration.

This proposal does not affect the performance period per se, but rather the deadline by which claims for items and services furnished during the performance period need to be processed for those items and services to be included in our calculation. To the extent that claims are used for submitting data on MIPS measures and activities to us, such claims would have to be processed by no later than 90 days after the end of the applicable performance period, in order for information on the claims to be included in our calculations. As noted above, if we determine that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we will utilize a 60-day duration. As an alternative to the above proposal, we also considered using claims that are paid within 60 days after 2017, for assessment of performance and application of the MIPS payment adjustment for 2019. We are seeking comment on both approaches.

Given the need to collect and process information, we propose at § 414.1320 that for 2019 and subsequent years, the performance period under MIPS would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS adjustment is applied. For example, the performance period for the 2019 MIPS adjustment would be the full calendar year 2017, that is, January 1, 2017 through December 31, 2017. We propose to use the 2017 performance year for the 2019 payment adjustment consistent with other CMS programs. This approach allows for a full year of measurement and sufficient time to base adjustments on complete and accurate information.

For individual MIPS eligible clinicians and group practices with less than 12 months of performance data to report, such as when a MIPS eligible clinician switches practices during the performance period or when a MIPS eligible clinician may have stopped practicing for some portion of the performance period (for example, a MIPS eligible clinician who is on maternity leave or has an illness), we propose that the individual MIPS eligible clinician or group would be required to report all performance data available from the performance period. Specifically, if a MIPS eligible clinician is reporting as an individual, they would report all partial year performance data. Alternatively, if the MIPS eligible clinician is reporting with a group, then the group would report all performance data available from the performance period, including partial year performance data available for the individual MIPS eligible clinician.

Under this approach, MIPS eligible clinicians with partial year performance data could achieve a positive, neutral, or negative MIPS adjustment based on their performance data. We propose this approach in order to incentivize accountability for all performance during the performance period. Two policies will help minimize the impact of partial year data. First, MIPS eligible clinicians with volume below the low-volume threshold would be excluded from any payment adjustments. Second, MIPS eligible clinicians who report measures, yet have insufficient sample size, would not be scored on those measures and activities refer to section II.E.6. of this proposed rule for further details.

To potentially refine this proposal in future years, we seek comment on methods to identify accurately MIPS eligible clinicians with less than 12-month reporting periods, notwithstanding common and expected absences due to illness, vacation, or holiday leave. Reliable identification of these MIPS eligible clinicians will allow us to analyze the characteristics of this MIPS eligible clinicians' patient population and better understand how a reduced reporting period impacts performance.

We also seek public comment on an alternative approach for future years for assessment of individual MIPS eligible clinicians with less than 12 months of performance data in the performance year. For example, if we can identify such MIPS eligible clinician's and confirm there are data issues that led to invalid performance calculations, then we could score the MIPS eligible clinician with a CPS equal to the performance threshold, which would result in a zero payment adjustment. We note this approach would not assess a MIPS eligible clinicians' performance for partial-year performance data. We do Start Printed Page 28181not believe that consideration of partial year performance is necessary for assessment of groups, which should have adequate coverage across MIPS eligible clinicians to provide valid performance calculations.

We also seek comment on reasonable thresholds for considering performance to be less than 12 months. For example, we expect that some MIPS eligible clinicians will take leave related to illness, vacation, and holidays. We would not anticipate applying special policies for lack of performance related to these common and expected absences assuming MIPS eligible clinicians' quality reporting includes measures with sufficient sample size to generate valid and reliable scores. We seek comment on how to account for MIPS eligible clinicians with extended leave that may affect measure sample size.

We request comments on these proposals and approaches.

5. MIPS Category Measures and Activities

a. Performance Category Measures and Reporting

(1) Statutory Requirements

Section 1848(q)(2)(A) of the Act requires the Secretary to use four performance categories in determining each MIPS eligible clinician's CPS under the MIPS: Quality; resource use; CPIA; and advancing care information. Section 1848(q)(2)(B) of the Act, subject to section 1848(q)(2)(C) of the Act, describes the measures and activities that, for purposes of the MIPS performance standards, must be specified under each performance category for a performance period.

Section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the MIPS quality performance category as the quality measures included in the annual final list of quality measures published under section 1848(q)(2)(D)(i) of the Act and the list of quality measures described in section 1848(q)(2)(D)(vi) of the Act used by QCDRs under section 1848(m)(3)(E) of the Act. Under section 1848(q)(2)(C)(i) of the Act, the Secretary must, as feasible, emphasize the application of outcome-based measures in applying section 1848(q)(2)(B)(i) of the Act. Under section 1848(q)(2)(C)(iii) of the Act, the Secretary may also use global measures, such as global outcome measures and population-based measures, for purposes of the quality performance category. Section 1848(q)(2)(B)(ii) of the Act describes the measures and activities that must be specified under the resource use performance category as the measurement of resource use for the performance period under section 1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.

Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use measures from other CMS payment systems, such as measures for inpatient hospitals, for purposes of the quality and resource use performance categories, except that the Secretary may not use measures for hospital outpatient departments, other than in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. This proposed rule seeks comment on how it might be feasible and when it might be appropriate to incorporate measures from other systems into MIPS for clinicians that work in facilities such as inpatient hospitals. For example, it may be appropriate to use such measures when other applicable measures are not available for individual MIPS eligible clinicians or when strong payment incentives are tied to measure performance, either at the facility level or with employed or affiliated MIPS eligible clinicians.

Section 1848(q)(2)(B)(iii) of the Act describes the measures and activities that must be specified under the CPIA performance category as CPIAs under subcategories specified by the Secretary for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act. Section 1848(q)(2)(C)(v)(III) of the Act defines a CPIA as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and geographic HPSAs in establishing CPIAs.

Section 1848(q)(2)(B)(iv) of the Act describes the measures and activities that must be specified under the advancing care information performance category as the requirements established for the performance period under section 1848(o)(2) for determining whether an eligible clinician is a meaningful EHR user.

As discussed in section II.E.1.b. of this proposed rule, section 1848(q)(2)(C)(iv) of the Act requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians in specifying measures and activities under the MIPS performance categories and allows the Secretary, to the extent feasible and appropriate, to take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category. In doing so, the Secretary is required to consult with non-patient facing professionals.

Section 101(b) of MACRA amends certain provisions of section 1848(k), (m), (o), and (p) of the Act to generally provide that the Secretary will carry out such provisions in accordance with section 1848(q)(1)(F) of the Act for purposes of MIPS. Section 1848(q)(1)(F) of the Act provides that, in applying a provision of section 1848(k), (m), (o), and (p) of the Act for purposes of MIPS, the Secretary must adjust the application of the provision to ensure that it is consistent with the MIPS requirements and must not apply the provision to the extent that it is duplicative with a MIPS provision.

(2) Submission Mechanisms

We propose at § 414.1325(a) that individual MIPS eligible clinicians and groups would be required to submit data on measures and activities for the quality, CPIA and advancing care information performance categories. As proposed at § 414.1325(f), we do not propose any data submission requirements for the resource use performance category and for certain quality measures used to assess performance on the quality performance category and for certain activities in the CPIA performance category. For the resource use performance category, we propose that each individual MIPS eligible clinician's and group's resource use performance would be calculated using administrative claims data. As a result, individual MIPS eligible clinicians and groups would not be required to submit any additional information for the resource use performance category. In addition, we would be using administrative claims data to calculate performance on a subset of the MIPS quality measures and the CPIA performance category. For this subset of quality measures and CPIAs, MIPS eligible clinicians and groups would not be required to submit additional information. For individual clinicians and groups that are not MIPS eligible clinicians, such as physical therapists, but elect to report to MIPS, we would calculate administrative claims resource use measures and quality measures, if data is available. We are proposing multiple data Start Printed Page 28182submission mechanisms for MIPS as outlined in Tables 1 and 2 to provide MIPS eligible clinicians with flexibility to submit their MIPS measures and activities in a manner that best accommodates the characteristics of their practice. We note that other terms have been used for these submission mechanisms in earlier programs and in industry. As a result, the terms used for the submission mechanisms may be refined in the final rule for clarity.

We propose at § 414.1325(d) that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending CPIA data, but a MIPS eligible clinician could not use two submission mechanisms for a single category such as submitting three quality measures via claims and three quality measures via registry. We believe the proposal to allow multiple mechanisms, while restricting the number of mechanisms per category, offers flexibility without adding undue complexity.Start Printed Page 28183

For individual MIPS eligible clinicians, we propose at § 414.1325(b), that an individual MIPS eligible clinician may choose to submit their quality, CPIA, and advancing care information data using qualified registry, QCDR, or EHR submission mechanisms. Furthermore, we propose at § 414.1400 that a qualified registry, health IT vendor, or QCDR could submit data on behalf of the MIPS eligible clinician for the three performance categories: Quality, CPIA, and advancing care information. As described in section II.E.9. of this proposed rule, these third party intermediaries would have to be qualified to submit for each of the performance categories. Additionally, we propose at § 414.1325(b)(4) and (5) that individual MIPS eligible clinicians may elect to report quality information via Medicare Part B claims and their CPIA and advancing care information performance category data through attestation.

For groups that are not reporting through the APM scoring standard, we propose at § 414.1325(c) that these groups may choose to submit their MIPS quality, CPIA, and advancing care information data using qualified registry, QCDR, EHR, or CMS Web Interface (for groups of 25+ MIPS eligible clinicians) submission mechanisms. Furthermore, we propose at § 414.1400 that a qualified registry, health IT vendor that obtains data from a MIPS eligible clinician's CEHRT, or QCDR could submit data on behalf of the group for the three performance categories: Quality, CPIA, and advancing care information. Additionally, groups may elect to submit their CPIA or advancing care information performance category data through attestation.

For those MIPS eligible clinicians participating in an APM that uses the APM scoring standard, we refer readers to section II.E.5.h. of this proposed rule, which describes how certain APM Entities submit data to MIPS, including separate approaches to the quality and resource use performance categories for APMs.

We propose one exception to the requirement for one reporting mechanism per category. Groups consisting of two or more eligible clinicians that elect to include CAHPS for MIPS as a quality measure must use a CMS-approved survey vendor. Their other quality information may be reported by any single one of the other proposed submission mechanisms.

While we allow MIPS eligible clinicians and groups to submit data for different performance categories via multiple submission mechanisms, we encourage MIPS eligible clinicians to submit MIPS information for the CPIA and advancing care information performance categories through the same reporting mechanism that is used for quality reporting. We believe it would reduce administrative burden and would simplify the data submission process for MIPS eligible clinicians by having a single reporting mechanism for all three performance categories for which MIPS eligible clinicians would be required to submit data: Quality, CPIA and advancing care information. However, we were concerned that not all third party entities would be able to implement the changes necessary to support reporting on all categories in the first year. We seek comments for future rulemaking on whether we should propose requiring health IT vendors, QCDRs and qualified registries to have the capability to submit data for all MIPS performance categories.

As we noted in this section of the proposed rule, we propose that MIPS eligible clinicians may report measures and activities using different submission methods across the performance categories. As we gain experience under MIPS, we anticipate that in future years it may be beneficial and reduce burden on MIPS eligible clinicians to require data for multiple performance categories to come through a single submission mechanism.

Further, we will be flexible in implementing MIPS. For example, if a MIPS eligible clinician submits data via multiple submission mechanisms (for example, registry and QCDR), we would score all the options and use the highest performance score for the eligible clinician or group as described in section II.E.6.a.(1)(b). However, we encourage eligible clinicians to report data for a given performance category using a single submission mechanism.

Finally, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the CPS methodology, to encourage MIPS eligible clinicians to report on applicable measures with respect to the quality performance category through the use of CEHRT and QCDRs. We note that this proposed rule uses the term CEHRT and certified health IT in different contexts. For an explanation of these terms and contextual use within this proposed rule, we refer readers to section II.E.5.g. of this proposed rule.

We have multiple policies to encourage the usage of QCDRs and CEHRT. In part, we are promoting the use of CEHRT by awarding bonus points in the quality scoring section for measures gathered and reported electronically via the QCDR, qualified registry, Web Interface, or CEHRT submission mechanisms (see II.E.6.b). By promoting use of CEHRT through various submission mechanisms, we believe MIPS eligible clinicians have flexibility in implementing electronic measure reporting in a manner which best suits their practice.

To encourage the use of QCDRs, we have created opportunities for QCDRs to report new and innovative quality measures. In addition, several CPIAs emphasize QCDR participation. Finally, we allow for QCDRs to report data on all MIPS performance categories that require data submission and hope this will become a viable option for MIPS eligible clinicians. We believe these flexible options will allow MIPS eligible clinicians to more easily meet the submission criteria for MIPS, which in turn will positively affect their CPS.

We request comments on these proposals.

(3) Submission Deadlines

For the submission mechanisms described in section II.E.5.a.(2) of this proposed rule, we propose a submission deadline whereby all associated data for all performance categories must be submitted. In establishing the submission deadlines, we have taken into account multiple considerations, including the type of submission mechanism, the MIPS performance period, and stakeholder input and our experiences under the submission deadlines for the PQRS, VM, and Medicare EHR Incentive Programs.

Historically, under the PQRS, VM or Medicare EHR Incentive Programs, the submission of data occurred after the close of the performance periods. Our experience has shown that allowing for the submission of data after the close of the performance period provides either the eligible clinician or the third party intermediary time to ensure the data they submit to us is valid, accurate and has undergone necessary data quality checks. Stakeholders have also stated that they would appreciate the ability to submit data to us on a more frequent basis so they can receive feedback more frequently throughout the performance period. We also note that, as described in section II.E.4. of this proposed rule, the MIPS performance period for payments adjusted in 2019 is calendar year 2017 (January 1 through December 31).

Based on the factors noted, we propose at § 414.1325(e) the data submission deadline for the qualified Start Printed Page 28184registry, QCDR, EHR, and attestation submission mechanisms would be March 31 following the close of the performance period. We anticipate that the submission period would begin January 2 following the close of the performance period. For example, for the first MIPS performance period, the data submission period would occur from January 2, 2018, through March 31, 2018. We note that this submission period is the same time frame as what is currently available to eligible professionals and group practices under PQRS. We are interested in receiving feedback on whether it is advantageous to either (1) have a shorter time frame following the close of the performance period, or (2) have a submission period that would occur throughout the performance period, such as bi-annual or quarterly submissions; and (3) whether January 1 should also be included in the submission period. We welcome comments on these items.

We further propose that for the Medicare Part B claims submission mechanism, the submission deadline would occur during the performance period with claims required to be processed no later than 90 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, the submission deadline will occur during an eight-week period following the close of the performance period that will begin no earlier than January 1 and end no later than March 31. For example, the CMS Web Interface submission period could span an 8 week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site.

We request comments on these proposals.

b. Quality Performance Category

(1) Background

(a) General Overview and Strategy

The MIPS program is one piece of the broader health care infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety for all Americans. We seek to balance the sometimes competing considerations of the health system and minimize burdens on health care providers given the short timeframe available under the MACRA for implementation. Ultimately, MIPS should, in concert with other provisions of the Act, support health care that is patient-centered, evidence-based, prevention-oriented, outcome driven, efficient, and equitable.

Under MIPS, clinicians are incentivized to engage in improvement measures and activities that have a proven impact on patient health and safety and are relevant to their patient population. We envision a future state where MIPS eligible clinicians will be seamlessly using their certified health IT to leverage advanced clinical quality measurement to manage patient population with the least amount of workflow disruption and reporting burden. Ensuring clinicians are held accountable for patients' transitions across the continuum of care is imperative. For example, when a patient is discharged from an emergency department to a primary care physician office, the emergency department clinicians should have a shared incentive for a seamless transition. Clinicians may also be working with a QCDR to abstract and report quality measures to CMS and commercial payers and to track patients longitudinally over time for quality improvement.

Ideally, clinicians in the MIPS program will have accountability for quality and resource use measures that are related to one another and will be engaged in CPIAs that directly help them improve in both specialty-specific clinical practice and more holistic areas (for example, patient experience, prevention, population health). Finally, MIPS eligible clinicians will be using CEHRT and other tools which leverage interoperable standards for data capture, usage, and exchange in order to facilitate and enhance patient and family engagement, care coordination among diverse care team members, and, in continuous learning and rapid-cycle improvement leveraging advanced quality measurement and safety initiatives.

One of our goals in the MIPS program is to use a patient-centered approach to program development that will lead to better, smarter, and healthier care. Part of that goal includes meaningful measurement which we hope to achieve through:

Measuring performance on measures that are relevant and meaningful.

Maximizing the benefits of CEHRT.

Flexible scoring that recognizes all of a MIPS eligible clinician's efforts above a minimum level of effort and rewards performance that goes above and beyond the norm.

Measures that are built around real clinical workflows and data captured in the course of patient care activities.

Measures and scoring that can discern meaningful differences in performance in each performance category and collectively between low and high performers.

(b) The MACRA Requirements

Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards and, using that methodology, to provide for a CPS for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the quality performance category in determining each MIPS eligible clinician's CPS, and section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the quality performance category.

The statute does not specify the number of quality measures on which a MIPS eligible clinician must report, nor does it specify the amount or type of information that a MIPS eligible clinician must report on each quality measure. However, section 1848(q)(2)(C)(i) of the Act requires the Secretary, as feasible, to emphasize the application of outcomes-based measures.

Sections 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary to encourage the use of CEHRT and QCDRs for reporting measures under the quality performance category under the CPS methodology, but the statute does not limit the Secretary's discretion to establish other reporting mechanisms.

Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient-facing MIPS eligible clinicians and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures or activities to such clinicians.

(c) Relationship to the PQRS and VM

Previously, the PQRS, which is a pay-for-reporting program, defined standards for satisfactory reporting and satisfactory participation to earn payment incentives or to avoid a payment adjustment EPs could choose from a number of reporting mechanisms and options. Based on the reporting option, the EP had to report on a certain number of measures for a certain portion of their patients. In addition, the measures had to span a set number of National Quality Strategy (NQS) domains, information related to the NQS can be found at http://www.ahrq.gov/​workingforquality/​about.htm. The VM built its policies off Start Printed Page 28185the PQRS criteria for avoiding the PQRS payment adjustment. Groups that did not meet the criteria as a group to avoid the PQRS payment adjustment or groups that did not have at least 50 percent of the EPs that did not meet the criteria as individuals to avoid the PQRS payment adjustment automatically received the maximum negative adjustment established under the VM and are not measured on their quality performance.

MIPS, in contrast to PQRS, is not a pay-for-reporting program, and we propose that it would not have a “satisfactory reporting” requirement. However, in order to develop an appropriate methodology for scoring the quality performance category, we believe that MIPS needs to define the expected data submission criteria and that the measures need to meet a data completeness standard. In this section we propose the minimum data submission criteria and data completeness standard for the MIPS quality performance category for the submission mechanisms that were proposed earlier in section II.E.5.a. The scoring methodology described in section II.E.6. of this proposed rule would adjust the quality performance category scores based on whether or not an individual MIPS eligible clinician or group met these criteria.

In the MIPS and APMs RFI, we requested feedback on numerous provisions related to data submission criteria including: How many measures should be required? Should we maintain the policy that measures cover a specified number of NQS domains? How do we apply the quality performance category to MIPS eligible clinicians that are in specialties that may not have enough measures to meet our defined criteria? Several themes emerged from the comments. Commenters expressed concern that the general PQRS satisfactory reporting requirement to report nine measures across three NQS domains is too high and forces eligible clinicians to report measures that are not relevant to their practices. The commenters requested a more meaningful set of requirements that focused on patient care, with some expressing the opinion that NQS domain requirements are arbitrary and make reporting more difficult. Some commenters asked that we align measures across payers and consider using core measure sets. Other commenters expressed the need for flexibility and different reporting options for different types of practices.

In response to the comments, and based on our desire to simplify the MIPS reporting system and make the measurement more meaningful, we are proposing MIPS quality criteria that focus on measures that are important to beneficiaries and maintain some of the flexibility from PQRS, while addressing several of the issues that concerned commenters.

To encourage meaningful measurement, we are proposing to allow individual MIPS eligible clinicians and groups the flexibility to determine the most meaningful measures and reporting mechanisms for their practice.

To simplify the reporting criteria, we are aligning the submission criteria for several of the reporting mechanisms.

To reduce administrative burden and focus on measures that matter, we are lowering the expected number of the measures for several of the reporting mechanisms, yet are still requiring that certain types of measures be reported.

To create alignment with other payers and reduce burden on MIPS eligible clinicians, we are incorporating measures that align with other national payers.

To create a more comprehensive picture of the practice performance, we are also proposing to use all-payer data where possible.

As beneficiary health is always our top priority, we propose criteria to continue encouraging the reporting of certain measures such as outcome, appropriate use, patient safety, efficiency, care coordination, or patient experience measures. However, we are proposing to remove the requirement for measures to span across multiple domains of the NQS. We continue to believe the NQS domains to be extremely important and we encourage MIPS eligible clinicians to continue to strive to provide care that focuses on: Effective clinical care, communication, efficiency and cost reduction, person and caregiver-centered experience and outcomes, community and population health, and patient safety. While we will not require that a certain number of measures must span multiple domains, we strongly encourage MIPS eligible clinicians to select measures that cross multiple domains. In addition, we believe the MIPS program overall, with the focus on resource use, CPIAs, and advancing care information performance categories will naturally cover many elements in the NQS.

(2) Contribution to Composite Performance Score (CPS)

For the 2019 MIPS adjustment year, the quality performance category will account for 50 percent of the CPS, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act states the quality performance category will account for 30 percent of the CPS for MIPS. However, section 1848(q)(2)(E)(i)(I)(bb) of the Act stipulates that for the first and second years for which MIPS applies to payments, the percentage of the CPS applicable for the quality performance category will be increased so that the total percentage points of the increase equals the total number of percentage points by which the percentage applied for the resource use performance category is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of the Act requires that, for the first year for which MIPS applies to payments, not more than 10 percent of the of CPS shall be based on performance to the resource use performance category. Furthermore, section 1848(q)(2)(E)(i)(II)(bb) of the Act states that, for the second year for which MIPS applies to payments, not more than 15 percent of the CPS shall be based on performance to the resource use performance category. We propose at § 414.1330 for payment years 2019 and 2020, 50 percent and 45 percent, respectively, of the MIPS CPS will be based on performance on the quality performance category. For the third and future years, 30 percent of the MIPS CPS will be based on performance on the quality performance category.

Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat any MIPS eligible clinician who fails to report on a required measure or activity as achieving the lowest potential score applicable to the measure or activity. Specifically, under our proposed scoring policies, a MIPS eligible clinician or group that reports on all required measures and activities could potentially obtain the highest score possible within the performance category, presuming they performed well on the measures and activities they reported. A MIPS eligible clinician or group who does not meet the reporting threshold would receive a zero score for the unreported items in the category (in accordance with section 1848(q)(5)(B)(i) of the Act). The MIPS eligible clinician or group could still obtain a relatively good score by performing very well on the remaining items, but a zero score would prevent the MIPS eligible clinician or group from obtaining the highest possible score.

(3) Quality Data Submission Criteria

(a) Submission Criteria

The following are the proposed criteria for the various proposed MIPS data submission mechanisms described above in section II.E.5.a. of this Start Printed Page 28186proposed rule for the quality performance category.

We propose at § 414.1335 that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding CMS Web Interface, and for CAHPS for MIPS survey, CMS-approved survey vendors) would be required to meet the following submission criteria. We propose that for the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C and including at least one outcome measure. If an applicable outcome measure is not available, we propose that the MIPS eligible clinician or group would be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then we propose the MIPS eligible clinician or group would be required to report on each measure that is applicable.

MIPS eligible clinicians and groups will have to select their measures from either the list of all MIPS measures in Table A or a set of specialty-specific measure set in Table E. Note that some specialty-specific measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level.

We designed the specialty-specific measure sets to address feedback we have received in the past that the quality measure selection process can be confusing. A common complaint about PQRS was that EPs were asked to review close to 300 measures to find applicable measures for their specialty. The specialty measure sets in Table E are the same measures that are within Table A, however these are sorted consistent with the American Board of Medical Specialties (ABMS) specialties. Please note that these specialty-specific measure sets are not all inclusive of every specialty or subspecialty. We request comments on the measures proposed under each of the specialty-specific measure sets. Specifically, we seek comments on whether or not the measures proposed for inclusion in the specialty-specific measure sets are appropriate for the designated specialty or sub-specialty and whether there are additional proposed measures that should be included in a particular specialty-specific measure set.

Furthermore, we note that there are some special scenarios for those MIPS eligible clinicians who select their measures from a specialty-specific measure set at either the specialty or subspecialty level (Table E). For example, some of the specialty-specific measure sets have less than six measures, in these instances MIPS eligible clinicians would report on all of the available measures including an outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures), within the set and a cross-cutting measure if they are a patient-facing MIPS eligible clinician. To illustrate, the subspecialty-level the electrophysiology cardiac specialist specialty-specific measure set only has three measures within the set, all of which are outcome measures. MIPS eligible clinicians and groups reporting on the electrophysiology cardiac specialist specialty-specific measure set would report on all three measures and since these MIPS eligible clinicians are patient-facing they must also report on a cross-cutting measure which is defined in Table C. In other scenarios, the specialty-specific measure sets may have six or more measures, in these instances MIPS eligible clinicians would report on at least six measures including at least one cross-cutting measure and at least one outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measure). Specifically, the general surgery specialty-specific measure set has eight measures within the set, including four outcome measures, three other high priority measures and one process measure. MIPS eligible clinicians and groups reporting on the general surgery specialty-specific measure set would either have the option to report on all measures within the set or could select six measures from the set and since these MIPS eligible clinicians are patient-facing one of their six measures must be a cross-cutting measure which is defined in Table C.

As noted above, the submission criteria for each specialty-specific measure set, or in the measure set defined at the subspecialty level, if applicable. Regardless of the number of measures that are contained in a specialty-specific measure set, MIPS eligible clinicians reporting on a measure set would be required to report at least one cross-cutting measure and either at least one outcome measure or, if no outcome measures are available in that specialty-specific measure set, report another high priority measure. MIPS eligible clinicians or groups that report on a specialty-specific measure set that includes more than six measures can report on as many measures as they wish as long as they meet the minimum requirement to report at least six measures, including one cross-cutting measure and one outcome measure, or if an outcome measure is not available another high priority measure. We seek comment on our proposal to allow reporting of specialty-specific measure sets to meet the submission criteria for the quality performance category, including whether it is appropriate to allow reporting of a measure set at the subspecialty level to meet such criteria, since reporting at the subspecialty level would require reporting on fewer measures. Alternatively, we seek comment on whether we should only consider reporting up to six measures at the higher overall specialty level to satisfy the submission criteria. We note that our proposal to allow reporting of specialty-specific measure sets at the subspecialty level was intended to address the fact that very specialized clinicians who may be represented by our subspecialty categories may only have one or two applicable measures. Further, we note that we will continue to work with specialty societies and other measure developers to increase the availability of applicable measures for specialists across the board.

We propose to define a high priority measure at § 414.1305 as an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measures. These measures are identified in Table A. We further note that measure types listed as an “intermediate outcome” are considered outcome measures for the purposes of scoring; see section II.E.6.

As an alternative to the above proposals, we also considered requiring individual MIPS eligible clinicians submitting via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding the CMS Web Interface and, for CAHPS for MIPS survey, CMS-approved survey vendors) to meet the following submission criteria. For the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C and one high priority measure (outcome, appropriate use, patient safety, efficiency, patient experience, and care Start Printed Page 28187coordination measures). If fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group must report on each measure that is applicable. MIPS eligible clinicians and groups will have to select their measures from either the list of all MIPS Measures in Table A or a set of specialty-specific measure set in Table E.

As discussed in section II.E.1.b. of this proposed rule, MIPS eligible clinicians who are non-patient-facing MIPS eligible clinicians would not be required to report any cross-cutting measures.

We intend to develop a validation process to review and validate a MIPS eligible clinician's or group's ability to report on at least six quality measures, or a specialty-specific measure set, with a sufficient sample size, including at least one cross-cutting measure (if the MIPS eligible clinician is patient-facing) and either an outcome measure if one is available or another high priority measure. If a MIPS eligible clinician or group had the ability to report on the minimum required measures with sufficient sample size and elects to report on fewer than the minimum required measures, then, as described in the proposed scoring algorithm in section II.E.6., the missing measures would be scored with a zero performance score.

Our proposal is a decrease from the 2016 PQRS requirement to report at least nine measures. In addition, as previously noted, we propose to no longer require reporting across multiple NQS domains. We believe these proposals are the best approach for the quality performance category because it decreases the MIPS eligible clinician's reporting burden while focusing on more meaningful types of measures.

We also note that we believe that outcome measures are more valuable than clinical process measures and are instrumental to improving the quality of care patients receive. To keep the emphasis on such measures in the statute, we plan to increase the requirements for reporting outcome measures over the next several years through future rulemaking, as more outcome measures become available. For example, we may increase the required number of outcome measures to two or three. We also believe that appropriate use, patient experience, safety, and care coordination measures are more relevant than clinical process measures for improving care of patients. Through future rulemaking, we plan to increase the requirements for reporting on these types of measures over time.

In consideration of which MIPS measures to identify as reasonably focused on appropriate use, we have selected measures which focus on minimizing overuse of services, treatments, or the related ancillary testing that may promote overuse of services and treatments. We have also included select measures of underuse of specific treatments or services that either (1) reflected overuse of alternative treatments and services that were are not evidence-based or supported by clinical guidelines; or (2) where the intent of the measure reflected overuse of alternative treatments and services that were not evidence-based or supported by clinical guidelines. We realize there are differing opinions on what constitutes appropriate use. Therefore, we are seeking comments on what specific measures of over or under use should be included as appropriate use measures.

We plan to continue developing care episode groups, patient condition groups, and patient relationship categories (and codes for such groups and categories). We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking. We also will closely examine the recommendations from HHS' Office of the Assistant Secretary for Planning and Evaluation (ASPE) study, once they are available, on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the IMPACT Act and incorporate them as feasible and appropriate through future rulemaking. In addition, we are seeking comments on ways to minimize potential gaming, for example, requiring MIPS eligible clinicians to report only on measures for which they have a sufficient sample size, to address concerns that MIPS eligible clinicians may solely report on measures that do not have a sufficient sample size to decrease the overall weight on their quality score. More information on the way we propose to score MIPS eligible clinicians in this scenario is in section II.E.6.a.2. We also seek comment on whether these proposals sufficiently encourage providers and measure developers to move away from clinical process measures and towards outcome measures and measures that reflect other NQS domains. We request comments on these proposals.

We propose at § 414.1335 the following criteria for the submission of data on quality measures by registered groups of 25 or more MIPS eligible clinicians who want to report via the CMS Web Interface. For the applicable 12-month performance period, we propose that the group would be required to report on all measures included in the CMS Web Interface completely, accurately, and timely by populating data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module/measure. If the pool of eligible assigned beneficiaries is less than 248, then the group would report on 100 percent of assigned beneficiaries. A group would be required to report on at least one measure for which there is Medicare patient data. We do not propose any modifications to this reporting process. Groups reporting via the CMS Web Interface are required to report on all of the measures in the set. Any measures not reported would be considered zero performance for that measure in our scoring algorithm.

Lastly, from our experience with using the CMS Web Interface under prior Medicare programs we are aware groups may register for this mechanism and have zero Medicare patients assigned and sampled to them. We clarify that should a group have no assigned patients, then the group, or individual MIPS eligible clinicians within the group, would need to select another mechanism to submit data to MIPS. If a group does not typically see Medicare patients for which the CMS Web Interface measures are applicable, or if the group does not have adequate billing history for Medicare patients to be used for assignment and sampling of Medicare patients into the CMS Web Interface, we advise the group to participate in the MIPS via another reporting mechanism.

As discussed in the CY 2016 PFS final rule with comment period (80 FR 71144), beginning with the 2017 PQRS payment adjustment, the PQRS aligned with the VM's beneficiary attribution methodology for purposes of assigning patients for groups that registered to participate in the PQRS Group Reporting Option (GPRO) using the CMS Web Interface (formerly referred to as the GPRO Web Interface). For certain quality and cost measures, the VM uses a two-step attribution process to associate beneficiaries with TINs during Start Printed Page 28188the period in which performance is assessed. This process attributes a beneficiary to the TIN that bills the plurality of primary care services for that beneficiary (79 FR 67960-67964). We propose to continue to align the 2019 CMS Web Interface beneficiary assignment methodology with the measures that used to be in the VM: the population quality measures discussed below in this proposed rule and total per capita cost for all attributed beneficiaries discussed in section II.E.5.e. of this proposed rule. As MIPS is a different program, we propose to modify the attribution process to update the definition of primary care services and to adapt the attribution to different identifiers used in MIPS. These changes are discussed in section II.E.5.e. of this proposed rule. We request comments on these proposals.

The CAHPS for MIPS survey (formerly known as the CAHPS for PQRS survey) consists of the core CAHPS Clinician & Group Survey developed by AHRQ, plus additional survey questions to meet CMS's information and program needs. For more information on the CAHPS for MIPS survey, please see the explanation of the CAHPS for PQRS survey in the CY 2016 PFS final rule with comment period (80 FR 71142 through 71143). While we anticipate that the CAHPS for MIPS survey will closely align with the CAHPS for PQRS survey, we may explore the possibility of updating the CAHPS for MIPS survey under MIPS, specifically we may not finalize all proposed Summary Survey Measures (SSM).

We propose to allow registered groups of two or more MIPS eligible clinicians to voluntarily elect to participate in the CAHPS for MIPS survey. Specifically, we propose at § 414.1335 the following criteria for the submission of data on the CAHPS for MIPS survey by registered groups via CMS-approved survey vendor: For the applicable 12-month performance period, the group must have the CAHPS for MIPS survey reported on its behalf by a CMS-approved survey vendor. In addition, the group will need to use another submission mechanism (that is, qualified registries, QCDRs, EHR etc.) to complete their quality data submission. The CAHPS for MIPS survey would count as one cross-cutting and/or a patient experience measure, and the group would be required to submit at least five other measures through one other data submission mechanisms. A group may report any five measures within MIPS plus the CAHPS for MIPS survey to achieve the six measures threshold.

The administration of the CAHPS for MIPS survey would contain a six-month look-back period. In previous years the CAHPS for PQRS survey was administered from November to February of the reporting year. We propose to retain the same survey administration period for the CAHPS for MIPS survey. Groups that voluntarily elect to participate in the CAHPS for MIPS survey would bear the cost of contracting with a CMS-approved survey vendor to administer the CAHPS for MIPS survey on the group's behalf, just as groups do now for the CAHPS for PQRS survey.

Under current provisions of PQRS, the CAHPS for PQRS survey is required for groups of 100 or more eligible clinicians. Although we are not requiring groups to participate in the CAHPS for MIPS survey, we do still believe patient experience is important and we are therefore proposing a scoring incentive for those groups who report via the CAHPS for MIPS survey. As described in section II.E.3.d. of this proposed rule, we propose that groups electing to report the CAHPS for MIPS survey, would be required to register for the reporting of data. Because we believe patients' experiences as they interact with the health care system is important, our proposed scoring methodology would give bonus points for reporting CAHPS data (or other patient experience measures). Please refer to section II.E.6. for further details. We are interested in receiving comments on whether the CAHPS for MIPS survey should be required for groups of 100 or more MIPS eligible clinicians or whether it should be voluntary.

Currently, the CAHPS for PQRS beneficiary sample is based on Medicare claims data. Therefore, only Medicare beneficiaries can be selected to participate in the CAHPS for PQRS survey. In future years of the MIPS program, we may consider expanding the potential patient experience measures to all payers, so that Medicare and non-Medicare patients can be included in the CAHPS for MIPS survey sample. We are seeking comments on criteria that would ensure comparable samples. We seek comments on these proposals.

(b) Data Completeness Criteria

We want to ensure that data submitted on quality measures are complete enough to accurately assess each MIPS eligible clinician's quality performance. Section 1848(q)(5)(H) of the Act provides that analysis of the quality performance category may include quality measure data from other payers, specifically, data submitted by MIPS eligible clinicians with respect to items and services furnished to individuals who are not individuals entitled to benefits under Part A or enrolled under Part B of Medicare.

To ensure completeness for the broadest group of patients, we propose at § 414.1340 the criteria below. MIPS eligible clinicians and groups who do not meet the proposed reporting criteria noted below would fail the quality component of MIPS.

Individual MIPS eligible clinicians or groups submitting data on quality measures using QCDRs, qualified registries, or via EHR need to report on at least 90 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for the performance period. In other words, for these submission mechanisms, we would expect to receive quality data for both Medicare and non-Medicare patients.

Individual MIPS eligible clinicians submitting data on quality measures data using Medicare Part B claims, would report on at least 80 percent of the Medicare Part B patients seen during the performance period to which the measure applies.

Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to report the CAHPS for MIPS survey would need to meet the data submission requirements on the sample of the Medicare Part B patients CMS provides.

We propose to include all-payer data for the QCDR, qualified registry, and EHR submission mechanisms because we believe this approach provides a more complete picture of each MIPS eligible clinicians scope of practice and provides more access to data about specialties and subspecialties not currently captured in PQRS. In addition, we propose the QCDR, qualified registry, or EHR submission must contain a minimum of one quality measure for at least one Medicare patient.

We desire all-payer data for all reporting mechanisms, yet certain reporting mechanisms are limited to Medicare Part B data. Specifically, the claims reporting mechanism relies on individual MIPS eligible clinicians attaching quality information on Medicare Part B claims; therefore only Medicare Part B patients can be reported by this mechanism. The CMS Web Start Printed Page 28189Interface and the CAHPS for MIPS survey currently rely on sampling protocols based on Medicare Part B billing; therefore, only Medicare Part B beneficiaries are sampled through that methodology. We welcome comments on ways to modify the methodology to assign and sample patients for these mechanisms using data from other payers.

The data completeness criteria we are proposing are an increase in the percentage of patients to be reported by each of the mechanisms when compared to PQRS. We believe the proposed thresholds are appropriate to ensure a more accurate assessment of a MIPS eligible clinician's performance on the quality measures and to avoid any selection bias that may exist under the current PQRS requirements. In addition, we would like to align all the reporting mechanisms as closely as possible with achievable data completeness criteria. We intend to continually assess the proposed data completeness criteria and will consider increasing these thresholds for future years of the program. We request comments on this proposal.

We are also interested in data that would indicate these data completeness criteria are inappropriate. For example, we could envision that reporting a cross-cutting measure would not always be appropriate for every telehealth service or for certain acute situations. We would not want a MIPS eligible clinician to fail reporting the measure in appropriate circumstances; therefore, we seek feedback data and circumstances where it would be appropriate to lower the data completeness criteria.

Section 1848(q)(2)(C)(iv) of the Act provides that the Secretary must give consideration to the circumstances of non-patient-facing MIPS eligible clinicians and may, to the extent feasible and appropriate, take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such clinicians. In doing so, the Secretary must consult with non-patient-facing MIPS eligible clinicians.

In addition, section 1848(q)(5)(F) to the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient-facing MIPS eligible clinician will not have sufficient measures and activities applicable and available to report and will not be scored on the quality performance category under MIPS. We refer readers to section II.E.6. of this proposed rule to discuss how we address performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given category.

In the MIPS and APMs RFI, we solicited feedback on how we should apply the four MIPS performance categories to non-patient-facing MIPS eligible clinicians and what types of measures and/or CPIAs (new or from other payments systems) would be appropriate for these MIPS eligible clinicians. We also engaged with seven separate organizations representing non-patient-facing MIPS eligible clinicians in the areas of anesthesiology, radiology/imaging, pathology, and nuclear medicine, specifically cardiology. Organizations we spoke with representing several specialty areas indicated that Appropriate Use Criteria (AUC) can be incorporated into the CPIA performance category by including activities related to appropriate assessments and reducing unnecessary tests and procedures. AUC are distinct from clinical guidelines and specify when it is appropriate to use a diagnostic test or procedure—thus reducing unnecessary tests and procedures. Use of AUC is an important CPIA as it fosters appropriate utilization and is increasingly used to improve quality in cardiovascular medicine, radiology, imaging, and pathology. These groups also highlighted that many non-patient-facing MIPS eligible clinicians have multiple patient safety and practice assessment measures and activities that could be included, such as activities that are tied to their participation in the Maintenance of Certification (MOC) Part IV for improving the clinician's practice. One organization expressed concern that because their quality measures are specialized, some members could be negatively affected when comparing quality scores because they did not have the option to be compared on a broader, more common set of measures. The MIPS and APMs RFI commenters noted that the emphasis should be on measures and activities that are practical, attainable, and meaningful to individual circumstances and that measurement should be as outcomes-based to the extent possible. The MIPS and APMs RFI commenters emphasized that CPIAs should be selected from a very broad array of choices and that ideally non-patient-facing MIPS eligible clinicians should help develop those activities so that they provide value and are easy to document. For more details regarding the CPIA performance category refer to section II.E.5.f. of this proposed rule. The comments from these organizations were considered in developing these proposals.

We understand that non-patient-facing MIPS eligible clinicians may have a limited number of measures on which to report. Therefore, we propose at § 414.1335 that non-patient-facing MIPS eligible clinicians would be required to meet the otherwise applicable submission criteria, but would not be required to report a cross-cutting measure.

Thus we would employ the following strategy for the quality performance criteria to accommodate non-patient-facing MIPS eligible clinicians:

Allow non-patient-facing MIPS eligible clinicians to report on specialty-specific measure set (which may have fewer than the required six measures).Start Printed Page 28192

Allow non-patient-facing MIPS eligible clinicians to report through a QCDR that can report non-MIPS measures.

Non-patient-facing MIPS eligible clinicians would be exempt from reporting a cross-cutting measure as proposed at § 414.1340.

We request comments on these proposals.

(5) Application of Additional System Measures

Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use measures used for payment systems other than for physicians, such as measures used for inpatient hospitals, for purposes of the quality and resource use performance categories. The Secretary may not, however, use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists.

In the MIPS and APMs RFI, we sought comment on how we could best use this authority. Some facility-based commenters requested a submission option that allows the MIPS eligible clinician to be scored based on the facility's measures. These commenters noted that the care they provide directly relates to and affects the facility's overall performance on quality measures and that using this score may be a more accurate reflection of the quality of care they provide than the quality measures in the PQRS or the VM program.

We will consider an option for facility-based MIPS eligible clinicians to elect to use their institution's performance rates as a proxy for the MIPS eligible clinician's quality score. We are not proposing an option for year 1 of MIPS because there are several operational considerations that must be addressed before this option can be implemented. We are requesting comment on the following issues: (1) Whether we should attribute a facility's performance to a MIPS eligible clinician for purposes of the quality and resource use performance categories and under what conditions such attribution would be appropriate and representative of the MIPS eligible clinician's performance; (2) possible criteria for attributing a facility's performance to a MIPS eligible clinician for purposes of the quality and resource use performance categories; and (3) the specific measures and settings for which we can use the facility's quality and resource use data as a proxy for the MIPS eligible clinician's quality and resource use performance categories; and (4) if attribution should be automatic or if a MIPS eligible clinician or group should elect for it to be done and choose the facilities through a registration process. We may also consider other options that would allow us to gain experience. We seek comments on these approaches.

(6) Global and Population-Based Measures

Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary may use global measures, such as global outcome measures, and population-based measures for purposes of the quality performance category.

Under the current PQRS program and Medicare EHR Incentive Program quality measures are categorized by domains which include global and population-based measures. We identified population and community health measures as one of the quality domains related to the CMS Quality Strategy and the NQS priorities for health care quality improvement discussed in section II.E.5.c. of this proposed rule. Population-based measures are also used in the Medicare Shared Savings Program and for groups in the VM. For example, in 2015, clinicians were held accountable for a component of the Agency for Health Care Research (AHRQ) population-based, Ambulatory Care Sensitive Condition measures as part of a larger set of Prevention Quality Indicators (PQIs). Two broader composite measures of acute and chronic conditions are calculated using the respective individual measure rates for VM calculations. These PQIs assess the quality of the health care system as a whole, and especially the quality of ambulatory care, in preventing medical complications that lead to hospital admissions.

In the CY 2015 PFS final rule with comment period (79 FR 67909), Medicare Payment Advisory Commission (MedPAC) commented that we should move quality measurement for ACOs, Medicare Advantage (MA) plans, and FFS Medicare in the direction of a small set of population-based outcome measures, such as potentially preventable inpatient hospital admissions, emergency department visits, and readmissions. In the June 2014 MedPAC Report to the Congress: Medicare and the Health Care Delivery System MedPAC suggests considering an alternative quality measurement approach that would use population-based outcome measures to publicly report on quality of care across Medicare's three payment models, FFS, Medicare Advantage, and ACOs.

In creating policy for global and population-based measures for MIPS we considered a more broad-based approach to the use of “global” and “population-based” measures in the MIPS quality performance category. After considering the above we propose to use the acute and chronic composite measures of Agency for Healthcare Research and Quality (AHRQ) Prevention Quality Indicators (PQIs) that meet a minimum sample size in the calculation of the quality measure domain for the MIPS total performance score; see Table B. Eligible clinicians will be evaluated on their performance on these measures in addition to the six required quality measures discussed previously and summarized in Table A. Based on experience in the VM program, these measures have been determined to be reliable with a minimum case size of 20. Average reliabilities for the acute and chronic measures range from 0.64 to 0.79 for groups and individual MIPS eligible clinicians. We intend to incorporate a clinical risk adjustment as soon as feasible to the PQI composites and continue to research ways to develop and use other population-based measures for the MIPS program that could be applied to greater numbers of MIPS eligible clinicians going forward. In addition to the acute and chronic composite measure, we also propose to include the all-cause hospital readmissions measure from the VM as we believe this measure also encourages care coordination. In the CY 2016 Medicare PFS final rule (80 FR 71296), we did a reliability analysis that indicates this measure is not reliable for solo clinicians or practices with fewer than 10 clinicians; therefore, we propose to limit this measure to groups with 10 or more clinicians and to maintain the current VM requirement of 200 cases. Eligible clinicians in groups with 10 or more clinicians with sufficient cases will be evaluated on their performance on this measure in addition to the six required quality measures discussed previously and summarized in Table A.

Furthermore, the proposed claims-based population measures would rely on the same two-step attribution methodology that is currently used in the VM (79 FR 67961 through 67694). The attribution focuses on the delivery of primary care services (77 FR 69320) by both primary care physicians and specialists. This attribution logic aligns with the total per capita measure and is similar to, but not exactly the same, as the assignment methodology used for the Shared Savings Program. For example, the Shared Savings Program definition of primary care services can Start Printed Page 28193be found at § 425.20 and excludes claims for certain Skilled Nursing Facility (SNF) services that include the POS 31 modifier). In section II.E.5.e.3.a.i. of this proposed rule, we propose to exclude the POS 31 modifier from the definition of primary care services. As described in section II.E.2. of this proposed rule, the attribution would be modified slightly to account for the MIPS eligible clinician identifiers. We are seeking comments on additional measures or measure topics for future years of MIPS and attribution methodology. We request comments on these proposals.

(1) Annual List of Quality Measures Available for MIPS Assessment

Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through notice and comment rulemaking, must establish an annual list of quality measures from which MIPS eligible clinicians may choose for purposes of assessment for a performance period. The annual list of quality measures must be published in the Federal Register no later than November 1 of the year prior to the first day of a performance period. Updates to the annual list of quality measures must be published in the Federal Register not later than November 1 of the year prior to the first day of each subsequent performance period. Updates may include the removal of quality measures, the addition of new quality measures, and the inclusion of existing quality measures that the Secretary determines have undergone substantive changes. For example, a quality measure may be considered for removal if the Secretary determines that the measure is no longer meaningful, such as measures that are topped out. A measure may be considered topped out if measure performance is so high and unvarying that meaningful distinctions and improvement in performance can no longer be made. Additionally, we are not the measure steward for most of the proposed quality measures available for inclusion in the MIPS annual list of quality measures. We rely on outside measure stewards and developers to maintain these measures. Therefore, we also propose to give consideration in removing measures that measure stewards are no longer able to maintain.

Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit a “Call for Quality Measures” each year. Specifically, the Secretary must request that eligible clinician organizations and other relevant stakeholders identify and submit quality measures to be considered for selection in the annual list of quality measures, as well as updates to the measures. Although we will accept quality measures submissions at any time, only measures submitted before June 1 of each year will be considered for inclusion in the annual list of quality measures for the performance period beginning 2 years after the measure is submitted. For example, a measure submitted prior to June 1, 2016 would be considered for the 2018 performance period. Of those quality measures submitted before June 1, we will determine which quality measures will move forward as potential measures for use in MIPS. Prior to finalizing new measures for inclusion in the MIPS program, those measures that we determine will move forward must also go through notice-and-comment rulemaking and the new proposed measures must be submitted to a peer review journal. Finally, for quality measures that have undergone substantive changes, we propose to identify measures including but not limited to measures that have had measure specification, measure title, and domain changes. Through NQF's or the measure steward's measure maintenance process, NQF-endorsed measures are sometimes updated to incorporate changes that we believe do not substantively change the intent of the measure. Examples of such changes may include updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. While we address such changes on a case-by-case basis, we generally believe these types of maintenance changes are distinct from substantive changes to measures that result in what are considered new or different measures.

In the first year of MIPS, we propose to maintain a majority of previously implemented measures in PQRS (80 FR 70885-71386) for inclusion in the annual list of quality measures. These measures can be found in the appendix at Table A: Proposed Individual Quality Measures Available for MIPS Reporting in 2017. Also included in the appendix in Table B is a list of quality measures that do not require data submission, some of which were previously implemented in the VM (80 FR 71273-71300), that we propose to include in the annual list of MIPS quality measures. These measures can be calculated from administrative claims data and do not require data submission. We are also proposing measures that were not previously finalized for implementation in the PQRS program. These measures and their draft specifications are listed in Table D. The proposed specialty-specific measure sets are listed in Table E. As we continue to develop measures and specialty-specific measure sets, we recognize that there are many MIPS eligible clinicians who see both Medicaid and Medicare patients and seek to align our measures to utilize Medicaid measures in the MIPS quality performance category. We believe that aligning Medicaid and Medicare measures is in the interest of all providers and will help drive quality improvement for our beneficiaries. For future years, we seek comment about the addition of a “Medicaid measure set” based on the CMCS Adult Core Set (https://www.medicaid.gov/​medicaid-chip-program-information/​by-topics/​quality-of-care/​adult-health-care-quality-measures.html). Measures we are proposing for removal can be found in Table F and measures that will have substantive changes for the 2017 performance period can be found in Table G. In future years, the annual list of quality measures available for MIPS assessment will occur through rulemaking. We request comment on these proposals. In particular, we seek comment on whether there are any measures that commenters believe should be classified in a different NQS domain than what was proposed or that should be classified as a different measure type (e.g., process vs. outcome) than what was proposed.

(2) Call for Quality Measures

Each year, we have historically solicited a “Call for Quality Measures” from the public for possible quality measures for consideration for the PQRS. Under MIPS, we propose to continue the annual “Call for Quality Measures” as a way to engage eligible clinician organizations and other relevant stakeholders in the identification and submission of quality measures for consideration. Under section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations are professional organizations as defined by nationally recognized specialty boards of certification or equivalent certification boards. However, we do not believe there needs to be any special restrictions on the type or make-up of the organizations carrying out the process of development of quality measures. Any such restriction would limit the development of quality measures and the scope and utility of the quality measures that may be considered for endorsement. Submission of potential quality measures regardless of whether they Start Printed Page 28194were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act, which is currently the National Quality Forum, is encouraged.

As previously noted, we encourage the submission of potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. However, consistent with the expectations established under PQRS, we propose to request that stakeholders apply the following considerations when submitting quality measures for possible inclusion in MIPS:

Measures that are not duplicative of an existing or proposed measure.

Measures that are beyond the measure concept phase of development and have started testing, at a minimum.

Measures that are outcome-based rather than clinical process measures.

Measures that address patient safety and adverse events.

Measures that identify appropriate use of diagnosis and therapeutics.

Measures that address the domain for care coordination.

Measures that address the domain for patient and caregiver experience.

Measures that address efficiency, cost and resource use.

Measures that address a performance gap or measurement gap.

We request comment on these proposals.

(3) Requirements

Section 1848(q)(2)(D)(iii) of the Act provides that, in selecting quality measures for inclusion in the annual final list of quality measures, the Secretary must provide that, to the extent practicable, all quality domains (as defined in section 1848(s)(1)(B) of the Act) are addressed by such measures and must ensure that the measures are selected consistent with the process for selection of measures under section 1848(k), (m), and (p)(2) of the Act.

Section 1848(s)(1)(B) of the Act defines “quality domains” as at least the following domains: clinical care, safety, care coordination, patient and caregiver experience, and population health and prevention. We believe the five domains applicable to the quality measures under MIPS are included in the NQS's six priorities as follows:

Patient Safety. These are measures that reflect the safe delivery of clinical services in all health care settings. These measures may address a structure or process that is designed to reduce risk in the delivery of health care or measure the occurrence of an untoward outcome such as adverse events and complications of procedures or other interventions. We believe this NQS priority corresponds to the domain of safety.

Person and Caregiver-Centered Experience and Outcomes. These are measures that reflect the potential to improve patient-centered care and the quality of care delivered to patients. They emphasize the importance of collecting patient-reported data and the ability to impact care at the individual patient level, as well as the population level. These are measures of organizational structures or processes that foster both the inclusion of persons and family members as active members of the health care team and collaborative partnerships with health care providers and provider organizations or can be measures of patient-reported experiences and outcomes that reflect greater involvement of patients and families in decision making, self-care, activation, and understanding of their health condition and its effective management. We believe this NQS priority corresponds to the domain of patient and caregiver experience.

Communication and Care Coordination. These are measures that demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, caregivers, and families to improve appropriate and timely patient and care team communication. They may also be measures that reflect outcomes of successful coordination of care. We believe this NQS priority corresponds to the domain of care coordination.

Effective Clinical Care. These are measures that reflect clinical care processes closely linked to outcomes based on evidence and practice guidelines or measures of patient-centered outcomes of disease states. We believe this NQS priority corresponds to the domain of clinical care.

Community/Population Health. These are measures that reflect the use of clinical and preventive services and achieve improvements in the health of the population served. They may be measures of processes focused on primary prevention of disease or general screening for early detection of disease unrelated to a current or prior condition. We believe this NQS priority corresponds to the domain of population health and prevention.

Efficiency and Cost Reduction. These are measures that reflect efforts to lower costs and to significantly improve outcomes and reduce errors. These are measures of cost, resource use and appropriate use of health care resources or inefficiencies in health care delivery.

Section 1848(q)(2)(D)(viii) of the Act provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures. Although not required to go through the pre-rulemaking process, we have found the NQF convened Measure Application Partnership's (MAP) input valuable. We propose that we may consider the MAP's recommendations as part of the comprehensive assessment of each measure considered for inclusion under MIPS. Elements we propose to consider in addition to those listed in the “Call for Quality Measures” section of this rule include a measure's fit within MIPS, if a measure fills clinical gaps, changes or updates to performance guidelines, and other program needs. Further, we will continue to explore how global and population-based measures can be expanded and plan to add additional population-based measures through future rulemaking. We request comment on these proposals.

(4) Peer Review

Section 1848(q)(2)(D)(iv) of the Act, requires the Secretary to submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures. The submission must include the method for developing and selecting such measures, including clinical and other data supporting such measures. We believe this opportunity for peer review helps ensure that new measures published in the final rule are meaningful and comprehensive. We propose to use the Call for Quality Measures process as an opportunity to gather the information necessary to draft the journal articles for submission from measure developers, measure owners and measure stewards since CMS does not always develop measures for the quality programs. Information from measure developers, measure owners and measure stewards will include but is not limited to: Background, clinical evidence and data that supports the intent of the measure; recommendation for the measure that may come from a study or the United States Preventive Task Force (USPTF) recommendations; and how this measure would align with the CMS Quality Strategy. The Call for Quality Measures is a yearlong process; however, to be aligned with the regulatory process, establishing the proposed measure set for the year Start Printed Page 28195generally begins in April and concludes in July. We will submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures. We request comment on this proposal. Additionally, we seek comment on mechanisms that could be used, such as the CMS Web site, to notify the public that the requirement to submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals is met. Additionally, we seek comment on the type of information that should be included in such notification.

(5) Measures for Inclusion

Under section 1848(q)(2)(D)(v) of the Act, the final annual list of quality measures must include, as applicable, measures from under section 1848(k), (m), and (p)(2) of the Act, including quality measures among: (1) Measures endorsed by a consensus-based entity; (2) measures developed under section 1848(s) of the Act; and (3) measures submitted in response to the “Call for Quality Measures” required under section 1848(q)(2)(D)(ii) of the Act. Any measure selected for inclusion that is not endorsed by a consensus-based entity must have an evidence-based focus. Further, under section 1848(q)(2)(D)(ix), the process under section 1890A of the Act is considered optional.

Section 1848(s)(1) of the Act, as added by section 102 of the MACRA, also requires the Secretary of Health and Human Services to develop a draft plan for the development of quality measures by January 1, 2016. We solicited comments from the public on the “Draft CMS Measure Development Plan” through March 1, 2016. The final CMS Measure Development Plan must be finalized and posted on the CMS Web site by May 1, 2016.

(6) Exception for QCDR Measures

Section 1848(q)(2)(D)(vi) of the Act provides that quality measures used by a QCDR under section 1848(m)(3)(E) of the Act are not required to be established through notice-and-comment rulemaking or published in the Federal Register; be submitted for publication in applicable specialty-appropriate, peer-reviewed journals, or meet the criteria described in section 1848(q)(2)(D)(v) of the Act. The Secretary must publish the list of quality measures used by such QCDRs on the CMS Web site. We propose to post the quality measures for use by qualified clinical data registries in the spring of 2017 for the initial performance period and no later than January 1 for future performance periods.

Quality measures that are owned or developed by the QCDR entity and proposed by the QCDR for inclusion in MIPS but are not a part of the MIPS quality measure set are considered non-MIPS measures. If a QCDR wants to use a non-MIPS measure for inclusion in the MIPS program for reporting, we propose that these measures go through a rigorous CMS approval process during the QCDR self-nomination period. Specific details on third party entity requirements can be found in section II.E.9 of this proposed rule. The measure specifications will be reviewed and each measure will be analyzed for its scientific rigor, technical feasibility, duplication to current MIPS measures, clinical performance gaps, as evidenced by background and/or literature review, and relevance to specialty practice quality improvement. Once the measures are analyzed, the QCDR will be notified of which measures are approved for implementation. Each non-MIPS measure will be assigned a unique ID that can only be used by the QCDR that proposed it. Although non-MIPS measures are not required to be NQF-endorsed, we encourage the use of NQF-endorsed measures and measures that have been in use prior to implementation in MIPS. Lastly, we note that MIPS eligible clinicians reporting via QCDR have the option of reporting MIPS measures included in Table A in the Appendix to the extent that such measures are appropriate for the specific QCDR and have been approved by CMS. We request comment on these proposals.

(7) Exception for Existing Quality Measures

Section 1848(q)(2)(D)(vii)(II) of the Act provides that any quality measure specified by the Secretary under section 1848(k) or (m) of the Act and any measure of quality of care established under section 1848(p)(2) of the Act for a performance or reporting period beginning before the first MIPS performance period (herein referred to collectively as “existing quality measures”) must be included in the annual list of MIPS quality measures unless removed by the Secretary. As discussed in section II.E.4 of this proposed rule, we are proposing that the performance period for the 2019 MIPS adjustment would be CY 2017, that is, January 1, 2017 through December 31, 2017. Therefore existing quality measures would consist of those that have been specified or established by the Secretary as part of the PQRS measure set or VM measure set for a performance or reporting period beginning before CY 2017.

Section 1848(q)(2)(D)(vii)(I) of the Act provides that existing quality measures are not required to be established through notice-and-comment rulemaking or published in the Federal Register (although they remain subject to the applicable requirements for removing measures and including measures that have undergone substantive changes), nor are existing quality measures required to be submitted for publication in applicable specialty-appropriate, peer-reviewed journals.

Section 1890A of the Act, as added by section 3014(b) of the ACA, requires that the Secretary establish a pre-rulemaking process under which certain steps occur for the selection of certain categories of quality and efficiency measures, one of which is that the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) convenes multi-stakeholder groups to provide input to the Secretary on the selection of such measures. These categories are described in section 1890(b)(7)(B) of the Act and include the quality measures selected for the PQRS. In accordance with section 1890A(a)(1) of the Act, the NQF convened multi-stakeholder groups by creating the MAP. Section 1890A(a)(2) of the Act requires that the Secretary make publicly available by December 1 of each year a list of the quality and efficiency measures that the Secretary is considering under Medicare. The NQF must provide the Secretary with the MAP's input on the selection of measures by February 1 of each year. The lists of measures under consideration for selection are available at http://www.qualityforum.org/​map/​.

Section 1848(q)(2)(D)(viii) of the Act provides that relevant eligible clinician organizations and other relevant stakeholders, including state and national medical societies, must be consulted in carrying out the annual list of quality measures available for MIPS assessment. Section 1848(q)(2)(D)(ii)(II) of the Act defines an eligible clinician organization as a professional organization as defined by nationally recognized specialty boards of certification or equivalent certification boards. Section 1848(q)(2)(D)(viii) of the Act further provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures.Start Printed Page 28196

Although MIPS quality measures are not required to go through the pre-rulemaking process under section 1890A of the Act, we have found the MAP's input valuable. The MAP process enables us to consult with relevant eligible professional organizations and other stakeholders, including state and national medical societies in finalizing the annual list of quality measures. In addition to the MAP's input this year, we also received input from the Core Measure Collaborative, specifically the America's Health Insurance Plans (AHIP), on core quality measure sets. The Core Measure Collaborative was organized by CMS in coordination with AHIP in 2014. This stakeholder workgroup has developed several condition-specific core measure sets to help align reporting requirements for private and public health insurance providers. Sixteen of the newly proposed measures under MIPS were recommended by the Core Measure Collaborative.

(9) Cross-Cutting Measures for 2017 and Beyond

Under PQRS we realized the value in requiring EPs to report a cross-cutting measure and have proposed to continue the use of cross-cutting measures under MIPS. The cross-cutting measures help focus our efforts on population health improvement and they also allow for meaningful comparisons between MIPS eligible clinicians. Under MIPS, we are proposing fewer cross-cutting measures than those available under PQRS for 2016 reporting; however, we believe the list contains measures for which all patient-facing MIPS eligible clinicians should be able to report, as the measures proposed include commonplace health improvement activities such as checking blood pressure and medication management. We have eliminated some measures for which the reporting MIPS eligible clinician may not actually be providing the care, but are just reporting another MIPS eligible clinician's performance result. An example of this would be a MIPS eligible clinician who never manages a diabetic patient's glucose, yet previously could have reported a measure about hemoglobin A1c based on an encounter. This type of reporting will likely not help improve or confirm the quality of care the MIPS eligible clinician provides to his or her patients. Although there are fewer proposed cross-cutting measures under MIPS, in previous years some measures were too specialized and could not be reported on by all MIPS eligible clinicians. The proposed cross-cutting measures under MIPS are more broadly applicable and can be reported on by most specialties. The proposed MIPS cross-cutting measure set will be available on the CMS Web site. Non-patient-facing MIPS eligible clinicians do not have a cross-cutting measure requirement. The cross-cutting measures that were available under PQRS for 2016 reporting that are not being proposed as cross-cutting measures for 2017 reporting are:

While we are proposing to remove the above listed measures from the cross-cutting measure set, these measures are being proposed to be available as individual quality measures available for MIPS reporting, some of which have proposed substantive changes. The proposed MIPS cross-cutting measure set can be found in Table C of the appendix of this proposed rule and will be available on the CMS Web site.

e. Resource Use Performance Category

(1) Background

(a) General Overview and Strategy

Measuring resource use is an integral part of measuring value. We envision the measures in the MIPS resource use performance category would provide MIPS eligible clinicians with the information they need to provide appropriate care to their patients and enhance health outcomes. In implementing the resource use performance category, we propose to start with existing condition and episode-based measures, and the total per capita costs for all attributed beneficiaries measure (total per capita cost measure). All resource use measures would be adjusted for geographic payment rate adjustments and beneficiary risk factors. In addition, a specialty adjustment would be applied to the total per capita cost measure. As detailed in section II.E.6.a.3 of this proposed rule, all of the measures attributed to a MIPS eligible clinician or group would be weighted equally within the resource use performance category, and there would be no minimum number of measures required to receive a score under the resource use performance category. We plan to draw on standards for measure reliability, patient attribution, risk adjustment, and payment standardization from the Physician Value-based Payment Modifier (Value Modifier or VM) as well as the Physician Feedback Program, as we believe many of the same measurement principles for cost measurement in the VM are applicable for measurement in the resource use performance category in MIPS.

All measures used under the resource use performance category would be derived from Medicare administrative claims data and as a result, participation would not require use of a data submission mechanism.

We plan to continue developing care episode groups, patient condition groups, and patient relationship categories (and codes for such groups and categories). We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking. We also will closely examine the recommendations from the HHS' Office of the Assistant Secretary for Planning and Evaluation (ASPE) study, when they are available, on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the IMPACT Act and incorporate them as feasible and appropriate through future rulemaking, under section 1848(q)(1)(G) of the Act.

(b) MACRA Requirements

Section 1848(q)(2)(A)(ii) of the Act establishes “resource use” as a performance category under the MIPS. Section 1848(q)(2)(B)(ii) of the Act describes the measures of the resource use performance category as the measurement of resource use for a MIPS performance period under section1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.

As discussed in section II.E.5.e.(1)(c) of this proposed rule, we previously established in rulemaking a value-based Start Printed Page 28197payment modifier, as required by section 1848(p) of the Act, that provides for differential payment to a physician or a group of physicians under the Physician Fee Schedule based on the quality of care furnished compared to cost. For the evaluation of costs of care, section 1848(p)(3) refers to appropriate measures of costs established by the Secretary that eliminate the effect of geographic adjustments in payment rates and take into account risk factors (such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals, such as to recognize that less healthy individuals may require more intensive interventions) and other factors determined appropriate by the Secretary.

Section 1848(r) of the Act specifies a series of steps and activities for the Secretary to undertake to involve the physician, practitioner, and other stakeholder communities in enhancing the infrastructure for resource use measurement, including for purposes of MIPS and APMs. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups. That section provides for care episode and patient condition groups to account for a target of an estimated one-half of expenditures under Parts A and B (with this target increasing over time as appropriate). We are required to take into account several factors when establishing these groups. For care episode groups, we must consider the patient's clinical problems at the time items and services are furnished during an episode of care, such as clinical conditions or diagnoses, whether or not inpatient hospitalization occurs, the principal procedures or services furnished, and other factors determined appropriate by the Secretary. For patient condition groups, we must consider the patient's clinical history at the time of a medical visit, such as the patient's combination of chronic conditions, current health status, and recent significant history (such as hospitalization and major surgery during a previous period), and other factors determined appropriate. We are required to post on the CMS Web site a draft list of care episode and patient condition groups and codes for solicitation of input from stakeholders, and subsequently post on the Web site an operational list of such groups and codes. As required by section 1848(r)(2)(H) of the Act, not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.

To facilitate the attribution of patients and episodes to one or more clinicians, section 1848(r)(3) of the Act requires the development of patient relationship categories and codes that define and distinguish the relationship and responsibility of a physician or applicable practitioner with a patient at the time of furnishing an item or service. These categories shall include different relationships of the clinician to the patient and reflect various types of responsibility for and frequency of furnishing care. We are required to post on the CMS Web site a draft list of patient relationship categories and codes for solicitation of input from stakeholders, and subsequently post on the Web site an operational list of such categories and codes. As required by section 1848(r)(3)(F) of the Act, not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.

Section 1848(r)(4) of the Act requires that claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, shall, as determined appropriate by the Secretary, include the applicable codes established for care episode groups, patient condition groups, and patient relationship categories under sections 1848(r)(2) and (3) of the Act, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner).

Under section 1848(r)(5) of the Act, to evaluate the resources used to treat patients, the Secretary shall, as determined appropriate, use the codes reported on claims under section 1848(r)(4) of the Act to attribute patients to one or more physicians and applicable practitioners and as a basis to compare similar patients, and conduct an analysis of resource use. In measuring such resource use, the Secretary shall use per patient total allowed charges for all services under Parts A and B (and, if the Secretary determines appropriate, Part D) and may use other measures of allowed charges and measures of utilization of items and services. The Secretary shall seek comments through one or more mechanisms (other than notice and comment rulemaking) from stakeholders regarding the resource use methodology established under section 1848(r)(5) of the Act.

(c) Relationship to the Value Modifier

Currently, the physician value-based payment modifier established under section 1848(p) of the Act utilizes six cost measures (see 42 CFR 414.1235): (1) A total per capita costs for all-attributed beneficiaries measure (which we will refer to as the total per capita cost measure); (2) a total per capita costs for all attributed beneficiaries with chronic obstructive pulmonary disease (COPD) measure; (3) a total per capita costs for all attributed beneficiaries with congestive heart failure (CHF) measure; (4) a total per capita costs for all attributed beneficiaries with coronary artery disease (CAD) measure; (5) a total per capita costs for all attributed beneficiaries with diabetes mellitus (DM) measure; and (6) a Medicare Spending Per Beneficiary (MSPB) measure.

Total per capita costs include payments under both Part A and Part B, but do not include Medicare payments under Part D for drug expenses. All cost measures for the VM are attributed at the physician group and solo practice level using the Medicare-enrolled billing TIN under a two-step attribution methodology. They are risk-adjusted and payment-standardized, and the expected cost is adjusted for the TIN's specialty composition. We refer readers to our discussions of these total per capita cost measures (76 FR 73433 through 73434, 77 FR 69315 through 69316), MSPB measure (78 FR 74774 through 74780, 80 FR 71295 through 71296), payment standardization methodology (77 FR 69316 through 69317 ), risk adjustment methodology (77 FR 69317 through 69318), and specialty adjustment methodology (78 FR 74781 through 74784) in earlier rulemaking for the VM. More information about these total per capita cost measures may be found in documents under the links titled “Measure Information Form: Overall Total Per Capita Cost Measure,” “Measure Information Form: Condition-Specific Total Per Capita Cost Measures,” and “Measure Information Form: Medicare Spending Per Start Printed Page 28198Beneficiary Measure” available at https://www.cms.gov/​medicare/​medicare-fee-for-service-payment/​physicianfeedbackprogram/​valuebasedpaymentmodifier.html.

The total per capita cost measures use a two-step attribution methodology that is similar, but not exactly the same, as the assignment methodology used for the Shared Savings Program. The attribution focuses on the delivery of primary care services (77 FR 69320) by both primary care clinicians and specialists. The MSPB measure has a different attribution methodology. It is attributed to the TIN that provides the plurality of Medicare Part B claims (as measured by allowable charges) during the index inpatient hospitalization. We refer readers to the discussion of our attribution methodologies (77 FR 69318 through 69320, 79 FR 67960 through 67964) in prior rulemaking for the VM.

These total per capita cost measures include payments for a calendar year and have been reported to TINs for several years through the Quality and Resource Use Reports (QRURs), which are issued as part of the Physician Feedback Program under section 1848(n) of the Act. The total per capita cost measures have been used in the calculation of the VM payment adjustments beginning with the 2015 payment adjustment period and the MSPB measure has been used in the calculation of the VM payment adjustments beginning with the 2016 payment adjustment period. More information about the current attribution methodology for these measures is available in the “Fact Sheet for Attribution in the Value-Based Payment Modifier Program” document available at https://www.cms.gov/​medicare/​medicare-fee-for-service-payment/​physicianfeedbackprogram/​valuebasedpaymentmodifier.html.

In the MIPS and APMs RFI (80 FR 59102 through 59113), we solicited feedback on the resource use performance category. Commenters directed our attention towards the “2015 Value-Based Payment Modifier Program Experience Report” (document available at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeedbackProgram/​Downloads/​2015-VM-Program-Experience-Rpt.pdf) for data demonstrating that physicians treating the largest shares of the Medicare's sickest patients are most likely to incur downward adjustments under the current program. Commenters suggested that CMS could risk adjust cost measures for differences in beneficiary characteristics impacting health and cost outcomes, and suggested that cost measure benchmarks could be stratified so that groups and solo practitioners are compared to other groups and individual practitioners treating beneficiaries with similar risk profiles. Commenters also expressed concern that current attribution methods are holding many clinicians accountable for costs they have no control over, while other clinicians have no patients attributed and no way of calculating accurate scores. Commenters generally believe episode-based costs could provide a more accurate measure in calculating resource use and comparing clinicians based on the cost of patient treatment episodes. Many commenters agreed that if properly selected and designed, measures tied to episodes of care could increase the relevance, reliability, and applicability of resource use measures and make feedback reports more actionable. However, in order for clinicians to be responsible for resource use, including episode-based costs, commenters strongly emphasized the need for access to timely and actionable information regarding these costs. Commenters have expressed concern that because certain VM measures were developed for hospitals they are not properly applied to clinician practices, which do not have Medicare patient populations large enough or heterogeneous enough to produce an accurate picture for resource use. Commenters requested that CMS make an effort to use resource measures which have been tested for use in clinician practices. Commenters supported development of new measures based on clinical guidelines and/or appropriate use criteria (AUC), and support the related “Choosing Wisely” campaign. In future years, individual specialties might decide to use AUC or “Choosing Wisely” guidelines in the creation of resource use measures applicable to their members. In these cases, CMS could consider adoption of evidence-based measures developed through a multi-specialty, clinician-led process.

(2) Weighting in the Composite Performance Score

As required by section 1848(q)(5)(E)(i)(II)(bb) of the Act, the resource use performance category shall make up no more than 10 percent of the CPS for the first MIPS payment year (CY 2019) and not more than 15 percent of the CPS the second MIPS payment year (CY 2020). Therefore, we propose at § 414.1350 that the resource use performance category would make up 10 percent of the CPS for the first MIPS payment year (CY 2019) and 15 percent of the CPS for the second MIPS payment year (CY 2020). As required by section 1848(q)(5)(E)(i)(II)(aa) of the Act and proposed at § 414.1350, starting with the third MIPS payment year and for each MIPS payment year thereafter, the resource use performance category would make up 30 percent of the CPS.

(3) Resource Use Criteria

As discussed above in section II.E.5.a. of this proposed rule, performance in the resource use performance category would be assessed using measures based on administrative Medicare claims data. At this time, we are not proposing any additional data submissions for the resource use performance category. As such, MIPS eligible clinicians and groups would be assessed based on resource use for Medicare patients only and only for patients that are attributed to them. MIPS eligible clinicians or groups that do not have enough attributed cases to meet or exceed the case minimums proposed in sections II.E.5.e.(3)(a)(ii) and II.E.5.e.(3)(b)(ii) would not be measured on resource use. For more discussion of MIPS eligible clinicians and groups without a resource use performance category score, please refer to II.E.6.a.(3)(d) and II.E.6.b.

For purposes of assessing performance of MIPS eligible clinicians on the resource use performance category, we propose at § 414.1350 to specify resource use measures for a performance period. For the CY 2017 MIPS performance period, we propose to utilize the total per capita cost measure, the MSPB measure, and several episode-based measures discussed in section II.E.5.e.3.b. of this proposed rule for the resource use performance category. The total per capita costs measure and the MSPB measure are described above in section II.E.5.e.(1)(c) of this proposed rule.

We propose including the total per capita cost measure as it is a global measure of all Part A and Part B resource use during the performance period and inclusive of the four condition specific measures under the VM (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus) for which performance tends to be correlated and its inclusion was supported by commenters on the MIPS and APMs RFI (80 FR 59102 through 59113). We also anticipate that MIPS eligible clinicians are familiar with the total per capita cost measure as the measure has been in the VM since 2015 Start Printed Page 28199and feedback has been reported through the annual QRUR to all groups starting in 2014.

We propose to adopt the MSPB measure because by the beginning of the initial MIPS performance period in 2017, we believe most MIPS eligible clinicians will be familiar with the measure in the VM or its variant under the Hospital Value Based Purchasing program. However, we propose two technical changes to the MSPB measure calculations for purposes of its adoption in MIPS which are discussed in the reliability section II.E.5.e.3.a.ii. of this proposed rule.

We propose to use the same methodologies for payment standardization, and risk adjustment for these measures for the resource use performance category as are defined for the VM. For more details on the previously adopted payment standardization methodology see 77 FR 69316 through 69317. For more details on the previously adopted risk adjustment methodology see 77 FR 69317 through 69318.

We are not proposing to include the VM total per capita cost measures for the four condition-specific groups (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus). Instead, we are generally proposing to assess performance as part of the episode-based measures proposed under section II.E.5.e.3.b. of this proposed rule. This shift is in response to feedback received as part of the MIPS and APMs RFI (80 FR 59102 through 59113). In the MIPS and APMs RFI, commenters stated that they do not believe the existing condition-based measures under the VM are relevant to their practice and expressed support for episode-based measures under MIPS.

(i) Attribution

In the VM, all cost measures are attributed to a TIN. In MIPS, however, we are proposing to evaluate performance at the individual and group levels. Please refer to section II.E.5.e.(3)(c) of this proposed rule, for our proposals to address attribution differences for individuals and groups. For purposes of this section, we will use the general term MIPS eligible clinicians to indicate attribution for individuals or groups.

For the MSPB measure, we propose to use attribution logic that is similar to what is used in the VM. MIPS eligible clinicians with the plurality of claims (as measured by allowable charges) for Medicare Part B services, rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the applicable performance period would be assigned the episode. The only difference from the VM attribution methodology would be that the MSPB measure would be assigned differently for individuals than for groups. For the total per capita cost measure, we propose to use a two-step attribution methodology that is similar to the methodology used in the 2017 and 2018 VM. We also propose to have the same two-step attribution process for the claims-based population measures in the quality performance category (section II.E.5.b.6.), CMS Web Interface measures, and CAHPS for MIPS. However, we also propose to make some modifications to the primary care services definition that is used in the attribution methodology to align with policies adopted under the Shared Savings Program.

The VM currently defines primary care services as the set of services identified by the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99340, 99341 through 99350, the welcome to Medicare visit (G0402), and the annual wellness visits (G0438 and G0439). We propose to update this set to include new care coordination codes that have been implemented in the Medicare Physician Fee Schedule: Transitional care management (TCM) codes (CPT codes 99495 and 99496) and the chronic care management (CCM) code (CPT code 99490). These services were added to the primary care service definition used by the Shared Saving Program in June 2015 (80 FR 32746 through 32748). We believe that these care coordination codes would also be appropriate for assigning services in the MIPS.

In the CY 2016 PFS final rule, the Shared Saving Program also finalized another modification to the primary care service definition: To exclude nursing visits that occur in a skilled nursing facility (SNF) (80 FR 71271 through 71272). Patients in SNFs (POS 31) are generally shorter stay patients who are receiving continued acute medical care and rehabilitative services. While their care may be coordinated during their time in the SNF, they are then transitioned back to the community. Patients in a SNF (POS 31) require more frequent practitioner visits—often from 1 to 3 times a week. In contrast, patients in nursing facilities (NFs) (POS 32) are almost always permanent residents and generally receive their primary care services in the facility for the duration of their life. Patients in the NF (POS 32) are usually seen every 30 to 60 days unless medical necessity dictates otherwise. We believe that it would be appropriate to follow a similar policy in MIPS; therefore, we propose to exclude services billed under CPT codes 99304 through 99318 when the claim includes the POS 31 modifier from the definition of primary care services.

We believe that making these two modifications would help align the primary care service definition between MIPS and Shared Savings Program and would improve the results from the 2-step attribution process.

We note, however, that while we are aligning the definition for primary care services, the 2-step attribution for MIPS would be different than the one used for the Shared Saving Program. We believe there are valid reasons to have differences between MIPS and the Shared Savings Program attribution. For example, as discussed in CY 2015 PFS final rule (79 FR 67960 through 67962), we eliminated the primary care service pre-step that is statutorily required for the Shared Savings Program from the VM. We noted that without the pre-step, the beneficiary attribution method would more appropriately reflect the multiple ways in which primary care services are provided, which are not limited to physician groups. As MIPS eligible clinicians include more than physicians, we continue to believe it is appropriate to exclude the pre-step.

In addition, in the 2015 Shared Saving Program final rule, we finalized a policy for the Shared Savings Program that we did not extend to the VM 2-step attribution: to exclude select specialties (such as several surgical specialties) from the second attribution step (80 FR 32749 through 32754). We do not believe it is appropriate to restrict specialties from the second attribution step for MIPS. If such a policy were adopted under MIPS, then all specialists on the exclusion list, unless they were part of a multispecialty group, would automatically be excluded from measurement on the total per capita cost measure, as well as on the claims-based population measures which rely on the same 2-step attribution. While we do not believe that many MIPS eligible clinicians or clinician groups with these specialties would be attributed enough cases to meet or exceed the case minimum, we believe that an automatic exclusion could remove some MIPS eligible clinicians and groups that should be measured for resource use.

We request comments on these proposed changes.

(ii) Reliability

Additionally, we seek to ensure that MIPS eligible clinicians and groups are measured reliably; therefore, we intend to use the 0.4 reliability threshold currently applied to measures under the Start Printed Page 28200VM to evaluate their reliability. A 0.4 reliability threshold standard means that the majority of MIPS eligible clinicians and groups who meet the case minimum required for scoring under a measure have measure reliability scores that exceed 0.4. We generally consider reliability levels between 0.4 and 0.7 to indicate “moderate” reliability and levels above 0.7 to indicate “high” reliability. In cases where we have considered high participation in the applicable program to be an important programmatic objective, such as the Hospital VBP Program, we have selected this 0.4 moderate reliability standard. We believe this standard ensures moderate reliability but does not substantially limit participation.

To ensure sufficient measure reliability for the resource use performance category in MIPS, we also propose at § 414.1380(b)(2)(ii) to use the minimum of 20 cases for the total per capita cost measure, the same case minimum that is being used for the VM. An analysis in the CY 2016 PFS final rule (80 FR 71282) confirms that this measure has high average reliability for solo practitioners (0.74) as well as for groups with more than 10 professionals (0.80).

In the CY 2016 PFS final rule, we finalized a policy that increases the minimum cases for the MSPB measure from 20 to 125 cases (80 FR 71295 through 71296) due to reliability concerns with the measure including the specialty adjustment. That said, we recognize that a case size increase of this nature also may limit the ability of MIPS eligible clinicians to be scored on MSPB, and have been evaluating alternative measure calculation strategies for potential inclusion under MIPS that better balance participation, accuracy, and reliability. As a result of this, we are proposing two modifications to the MSPB measure.

The first technical change we are proposing is to remove the specialty-adjustment from the MSPB measure's calculation. As currently reported on the QRURs, the MSPB measure is risk adjusted to ensure that these comparisons account for case-mix differences between practitioners' patient populations and the national average. It is unclear that the current additional adjustment for physician specialty improves the accounting for case-mix differences for acute care patients, and thus, may not be needed.

The second technical change we propose is to modify the cost ratio used within the MSPB equation to evaluate the difference between observed and expected episode cost at the episode level before comparing the two at the individual or group level. In other words, rather than summing all of the observed costs and dividing by the sum of all the expected costs, we would take the observed to expected cost ratio for each MSPB episode assigned to the MIPS eligible clinician or group and take the average of the assigned ratios. As we did previously, we would take the average for the MIPS eligible clinician or group and multiply it by the average of observed costs across all episodes nationally.

Our analysis, which is based on all Medicare Part A and B claims data for beneficiaries discharged from an acute inpatient hospital between January 1, 2013 and December 1, 2013, indicates that these two changes would improve the MSPB measure's ability to calculate costs and the accuracy with which it can be used to make clinician-level performance comparisons. We also believe that these changes would help ensure the MSPB measure can be applied to a greater number of MIPS eligible clinicians while still maintaining its status as a reliable measure. More specifically, our analysis indicates that after making these changes to the MSPB measure's calculations, the MSPB measure meets the desired 0.4 reliability threshold used in the VM for over 88 percent of all TINs with a 20 case minimum, including solo practitioners. While this percentage is lower than our current policy for the VM (where virtually all TINs with 125 or more episodes have moderate reliability), setting the case minimum at 20 allows for an increase in participation in the MSPB measure. Therefore, we propose at § 414.1380(b)(2)(ii) to use a minimum of 20 cases for the MSPB measure. As noted previously, we consider expanded participation of MIPS eligible clinicians, particularly individual reporters, to be of great import for the purposes of transitioning to MIPS and believe that this justifies a slight decrease of the percentage of TINs meeting the reliability threshold.

As noted in the previous section, we are proposing to calculate several episode-based measures for inclusion in the resource use performance category. Groups have received feedback on their performance on episode-based measures through the Supplemental Quality and Resource Use Report (sQRUR), which are issued as part of the Physician Feedback Program under section 1848(n) of the Act; however, these measures have not been used for payment adjustments through the VM. Several stakeholders expressed in the MIPS and APMs RFI the desire to transition to episode-based measures and away from the general total per capita measures used in the VM. Therefore, in lieu of using the total per capita cost measures for populations with specific conditions that are used for the VM, we are proposing episode-based measures for a variety of conditions and procedures that are high cost, have high variability in resource use, or are for high impact conditions. In addition, as these measures are payment standardized and risk adjusted, we believe they meet the statutory requirements for appropriate measures of cost as defined in section 1848(p)(3) of the Act because the methodology eliminates the effects of geographic adjustments in payment rates and takes into account risk factors.

We also reiterate that while we transition to using episode-based measures for payment adjustments, we will continue to engage stakeholders through the process specified in section 1848(r)(2) of the Act to refine and improve the episodes moving forward.

As noted earlier, we have provided performance information on episode-based measures to MIPS eligible clinicians through the Supplemental Quality and Resource Use Reports (sQRURs), which are released in the Fall. The sQRURs provide groups and solo practitioners with information to evaluate their resource utilization on conditions and procedures that are costly and prevalent in the Medicare FFS population. To accomplish this goal, various episodes are defined and attributed to one or more groups or solo practitioners most responsible for the patient's care. The episode-based measures include Medicare Part A and Part B payments for services determined to be related to the triggering condition or procedure. The payments included are standardized to remove the effect of differences in geographic adjustments in payment rates and incentive payment programs and they are risk adjusted for the clinical condition of beneficiaries. Although the sQRURs provide detailed information on these care episodes, the calculations are not used to determine a TIN's VM payment adjustment and are only used to provide feedback.

We propose to include in the resource use performance category several clinical condition and treatment episode-based measures that have been reported in the sQRUR or were included in the list of the episode groups developed under section 1848(n)(9)(A) Start Printed Page 28201of the Act published on the CMS Web site: https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Value-Based-Programs/​MACRA-MIPS-and-APMs/​MACRA-MIPS-and-APMs.html. The identified episode-based measures have been tested and previously published. Tables 4 and 5 list the 41 clinical condition and treatment episode-based measures proposed for the CY 2017 MIPS performance period, as well as whether the episodes have previously been reported in a sQRUR.

The measures listed in Table 4 were developed under section 1848(n)(9)(A) of the Act, which required the Secretary to develop an episode grouper that combines separate but clinically related items and services into an episode of care for an individual, as appropriate, and provide reports on utilization to physicians (episode grouping Method A). The proposed measures accommodate both chronic and acute procedure episodes. The measures are also specifically designed to accommodate episodes that are initiated by physician claims, and section 1848(r)(4) of the Act requires claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, to include (as determined appropriate by the Secretary) the applicable codes established for care episode groups, patient condition groups, and patient relationship categories. The episodes and logic have undergone detailed and rigorous evaluation by an independent evaluation contractor and CMS also reviewed for clinical validity.

Table 5 shows a second set of proposed measures that were developed to complement previous CMS efforts and to provide additional episode types to report in the supplemental QRURs. These measures represent acute conditions and procedures that are costly and prevalent in the Medicare FFS population. These measures examine services independently, regardless of other episodes a patient may be experiencing, and episodes do not interact with each other (episode grouping Method B).

Some of the episode types listed in Table 5 have subtypes that provide additional clinical detail and improve the actionability of data reported on these episode types, as well as comparability to expected costs. All episode types were developed with clinical input and complement the existing MSPB measure currently used in the VM. In addition, all episode types were reported in 2014 sQRURs.

While we are proposing the measures listed in Tables 4 and 5 for the resource use performance category, we are uncertain as to how many of these measures we will ultimately include in the final rule. As these measures have never been used for payment purposes, we may choose to specify a subset of these measures in the final rule. We request public comment on which of the measures listed in Tables 4 and 5 to include in the final rule. In addition to considering public comments, we intend to consider the number of MIPS eligible clinicians able to be measured, the episode's impact on Medicare Part A and Part B spending, and whether the measure has been reported through sQRUR. In addition, while we do not believe specialty adjustment is necessary for the episode-based measures, we will continue to explore this further given the diversity of episodes. We seek comment on whether we should specialty adjust the episode-based measures.

Acute condition episodes would be attributed to all MIPS eligible clinicians that bill at least 30 percent of inpatient evaluation and management (IP E&M) visits during the initial treatment, or “trigger event,” that opened the episode. E&M visits during the episode's trigger event represent services directly related to the management of the beneficiary's acute condition episode. MIPS eligible clinicians that bill at least 30 percent of IP E&M visits are therefore likely to have been responsible for the oversight of care for the beneficiary during the episode. It is possible for more than one MIPS eligible clinician to be attributed a single episode using this rule. If an acute condition episode has no IP E&M claims during the episode, then that episode is not attributed to any MIPS eligible clinician.

Procedural episodes would be attributed to all MIPS eligible clinicians that bill a Medicare Part B claim with a trigger code during the trigger event of the episode. For inpatient procedural episodes, the trigger event is defined as the IP stay that triggered the episode plus the day before the admission to the IP hospital. For outpatient procedural episodes constructed using Method A, the trigger event is defined as the day of the triggering claim plus the day before and two days after the trigger date. For outpatient procedural episodes constructed using Method B, the trigger event is defined as only the day of the triggering claim. Any Medicare Part B claim or line during the trigger event with the episode's triggering procedure code is used for attribution. If more than one MIPS eligible clinician bills a triggering claim during the trigger event, the episode is attributed to each of the MIPS eligible clinicians. If co-surgeons bill the triggering claim, the episode is attributed to each MIPS eligible clinician. If only an assistant surgeon bills the triggering claim, the episode is attributed to the assistant surgeon or group. If an episode does not have a concurrent Part B claim with a trigger code for the episode, then that episode is not attributed to any MIPS eligible clinician.

(ii) Reliability

To ensure moderate reliability, we propose at § 414.1380(b)(2)(ii) to use the minimum of 20 cases for all episode-based measures listed in Tables 4 and 5. We propose to not include any measures that do not have average moderate reliability (at least 0.4) at 20 episodes.

(c) Attribution for Individual and Groups

In the VM and sQRUR, all resource use measurement was attributed at the solo practitioner and group level, as identified by TIN. In MIPS, however, we are proposing to evaluate performance at the individual and group levels. For MIPS eligible clinicians whose performance is being assessed individually across the other MIPS performance categories, we propose to attribute resource use measures using TIN/NPI rather than TIN. Attribution at the TIN/NPI level allows individual MIPS eligible clinicians, as identified by their TIN/NPI, to be measured based on cases that are specific to their practice, rather than being measured on all the cases attributed to the group TIN. For MIPS eligible clinicians that choose to have their performance assessed as a group across the other MIPS performance categories, we propose to attribute resource use measures at the TIN level (the group TIN under which they report). The logic for attribution would be similar whether attributing to the TIN/NPI level or the TIN level. As an alternative proposal, we seek comment on whether MIPS eligible clinicians that choose to have their performance assessed as a group should first be attributed at the individual TIN/NPI level and then have all cases assigned to the individual TIN/NPIs attributed to the group under which they bill. This alternative would apply one consistent methodology to both groups and individuals, compared to having a methodology that assigns cases using TIN/NPI for assessment at the individual level and another that assigns cases using only TIN for assessment at the group level. For example, the general attribution logic for MSPB is to assign the MSPB measure based on the plurality of claims (as measured by allowable charges) for Medicare Part B services rendered during an inpatient hospitalization that is an index admission for the MSPB measure. Our proposed approach would determine “plurality of claims” separately for individuals and groups. For individuals, we would assign the MSPB measure using the “plurality of claims” by TIN/NPI, but for groups we would determine the “plurality of claims” by TIN. The alternative proposal, in contrast, would determine the “plurality of claims” by TIN/NPI for both groups and individuals. However, for individuals, only the MSPB measure attributed to the TIN/NPI would be evaluated, while for groups the MSPB measure attributed to any TIN/NPI billing under the TIN would be evaluated.

Section 101(c) of the MACRA added section 1848(q)(2)(C)(iv) to the Act, which requires the Secretary to give consideration to the circumstances of professional types who typically furnish services without patient facing interaction (non-patient-facing) when determining the application of measures and activities. In addition, this section allows the Secretary to apply alternative measures or activities to non-patient facing MIPS eligible clinicians that fulfill the goals of a performance category. Section 101(c) of the MACRA also added section 1848(q)(5)(F) to the Act, which allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of eligible clinician involved.

For the 2017 MIPS performance period, we are not proposing any alternative measures for non-patient facing MIPS eligible clinicians or groups. This means that non-patient facing MIPS eligible clinicians or groups may not be attributed any resource use measures that are generally attributed to clinicians who have patient facing encounters with patients. We therefore anticipate that, similar to MIPS eligible clinicians or groups that do not meet the required case minimum for any resource use measures, many non-patient facing MIPS eligible clinicians may not have sufficient measures and activities available to report and would not be scored on the resource use performance category under MIPS. We refer readers to section II.E.6.b.2. of this proposed rule where we discuss how we would address performance category weighting for MIPS eligible clinicians or groups who do not receive a performance category score for a given performance category. We also intend to work with non-patient facing MIPS eligible clinicians and specialty societies to propose alternative resource use measures for non-patient facing MIPS eligible clinicians and groups under MIPS in future years. Lastly, we seek comment on how best to incorporate appropriate alternative resource use measures for all MIPS eligible clinician types, including non-patient facing MIPS eligible clinicians.

(e) Additional System Measures

Section 1848(q)(2)(C)(ii) of the Act, as added by section 101(c) of MACRA Start Printed Page 28209provides that the Secretary may use measures used for a payment system other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and resource use performance categories of MIPS. The Secretary, however, may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists.

We intend to align any facility-based MIPS measure decision across the quality and resource use performance categories to ensure consistent policies for MIPS in future years. We refer readers back to section II.E.5.b.5. of this proposed rule, which discusses our strategy and solicits comments related to this provision.

(4) Future Modifications to Resource Use Performance Category

In the future, we intend to consider how best to incorporate Part D costs into the resource use performance category, as described in section 1848(q)(2)(B)(ii) of the Act. We seek public comments on how we should incorporate those costs under MIPS for future years. We also intend to continue developing and refining episode groups for purposes of resource use performance category measure calculations.

f. Clinical Practice Improvement Activity (CPIA) Category

(1) Background

(a) General Overview and Strategy

The CPIA performance category focuses on one of our MIPS strategic goals, to use a patient-centered approach to program development that leads to better, smarter, and healthier care. We believe improving the health of all Americans can be accomplished by developing incentives and policies that drive improved patient health outcomes. CPIAs emphasize activities that have a proven association with improved health outcomes. The CPIA performance category also focuses on another MIPS strategic goal which is to use design incentives that drive movement toward delivery system reform principles and APMs. Another MIPS strategic goal we are striving to achieve is to establish policies that can be scaled in future years as the bar for improvement rises. Under the CPIA performance category we are proposing baseline requirements that will continue to have more stringent requirements in future years, and lay the groundwork for expansion towards continuous improvement over time.

(b) The MACRA Requirements

Section 1848(q)(2)(C)(v)(III) of the Act defines a CPIA as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery, and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to specify CPIAs under subcategories for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act, and in doing so to give consideration to the circumstances of small practices (consisting of 15 or fewer clinicians), and practices located in rural areas and geographic health professional shortage areas (HPSAs).

Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient-facing MIPS eligible clinicians or groups and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures and activities to such MIPS eligible clinicians and groups.

Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a request for information (RFI) to solicit recommendations from stakeholders to identify CPIAs and specify criteria for such CPIAs, and provides that the Secretary may contract with entities to assist in identifying activities, specifying criteria for the activities, and determining whether MIPS eligible clinicians or groups meet the criteria set. In the MIPS and APMs RFI, we requested recommendations to identify activities and specify criteria for activities. In addition, we requested details on how data should be submitted, the number of activities, how performance should be measured, and what considerations should be made for small and/or rural practices. There were two overarching themes from the comments that we received. First, the majority of the comments indicated that all subcategories should be weighted equally and that MIPS eligible clinicians or groups should be allowed to select from whichever subcategories are most applicable to them during the performance period. Second, commenters supported inclusion of a diverse set of activities that are meaningful for individual MIPS eligible clinicians or groups. We have reviewed all of the comments that we received and have taken these recommendations into consideration while developing the proposed CPIA policies.

(2) Contribution to Composite Performance Score (CPS)

Section 1848(q)(5)(E)(i)(III) of the Act specifies that the CPIA performance category will account for 15 percent of the CPS, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Therefore, we propose at § 414.1355, that the CPIA performance category will account for 15 percent of the CPS.

Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician or group that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period must be given the highest potential score for the CPIA performance category for the performance period. For a further description of APMs that have a certified patient centered-medical home designation, we refer readers to section II.E.5.h.

A patient-centered medical home will be recognized if it is a nationally recognized accredited patient-centered medical home, a Medicaid Medical Home Model, or a Medical Home Model. The NCQA Patient-Centered Specialty Recognition will also be recognized, which qualifies as a comparable specialty practice. Nationally recognized accredited patient-centered medical homes are recognized if they are accredited by: (1) The Accreditation Association for Ambulatory Health Care; (2) the National Committee for Quality Assurance (NCQA) PCMH recognition; (3) The Joint Commission Designation; or (4) the Utilization Review Accreditation Commission (URAC).[8]
We refer readers to section II.F. of this proposed rule for further description of the Medicaid Medical Home Model or Medical Home Model.9 The criteria for being a nationally recognized accredited patient-centered medical home is that it must be national in scope and must have evidence of being used by a large number of medical organizations as the model for their patient-centered medical home. We seek comment on our proposal for determining which practices would qualify as patient-centered medical homes. We also note that practices may receive a patient-centered medical home designation at a practice level, and that individual TINs may be composed of both undesignated practices and practices that have Start Printed Page 28210received a designation as a patient-centered medical home (for example, only one practice site has received patient-centered medical home designation in a TIN that includes five practice sites). For MIPS eligible clinicians who choose to report at the group level, reporting is required at the TIN level. We solicit comment on how to provide credit for patient-centered medical home designations in the calculation of the CPIA performance category score for groups when the designation only applies to a portion of the TIN (for example, to only one practice site in a TIN that is comprised of five practice sites).

Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible clinicians or groups who are participating in an APM (as defined in section 1833(z)(3)(C) of the Act) for a performance period must earn at least one half of the highest potential score for the CPIA performance category for the performance period. For further description of CPIA and the APM scoring standard for MIPS, we refer readers to section II.E.5.h. For all other MIPS eligible clinicians or groups, this section applies and we also refer readers to the scoring requirements for MIPS eligible clinicians and groups in section II.E.6. of this proposed rule.

Section 1848(q)(5)(C)(iii) of the Act provides that a MIPS eligible clinician or group must not be a MIPS eligible clinician or group required to perform activities in each CPIA subcategory or participate in an APM to achieve the highest potential score for the CPIA performance category.

Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat a MIPS eligible clinician or group that fails to report on an applicable measure or activity that is required to be reported, they will receive the lowest potential score applicable to the measure or activity.

(3) CPIA Data Submission Criteria

(a) Submission Mechanisms

For the purpose of submitting under the CPIA performance category, we proposed in section II.E.5.a. of this proposed rule to allow for submission of data for the CPIA performance category using the qualified registry, EHR, QCDR, CMS Web Interface and attestation data submission mechanisms. If technically feasible, we will use administrative claims data to supplement the CPIA submission. Regardless of the data submission method, all MIPS eligible clinicians or groups must select activities from the CPIA Inventory provided in Table H of the Appendices. We believe the proposed data submission methods will allow for greater access and ease in submitting data, as well as consistency throughout the MIPS program.

In addition, we propose at § 414.1360, that for the first year only, all MIPS eligible clinicians or groups, or third party entities such as health IT vendors, QCDRs and qualified registries that submit on behalf of a MIPS eligible clinician or group, must designate a yes/no response for activities on the CPIA Inventory. In the case where a MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, the MIPS eligible clinician or group will certify all CPIAs have been performed and the health IT vendor, QCDR, or qualified registry will submit on their behalf. An agreement between a MIPS eligible clinician or group and a health IT vendor, QCDR, or qualified registry for data submission for CPIA as well as other performance data submitted outside of the CPIA performance category could be contained in a single agreement, minimizing the burden on the MIPS eligible clinician or group. See section II.E.9 for additional details.

We propose to use the administrative claims method, if technically feasible, only to supplement CPIA submissions. For example, if technically feasible, MIPS eligible clinicians or groups, using the telehealth modifier GT, could get automatic credit for this activity. We request comments on these proposals.

(b) Weighted Scoring

While we considered both equal and differentially weighted scoring in this performance category, the statute requires a differentially weighted scoring model by requiring 100 percent of the potential score in the CPIA performance category for patient-centered medical home participants, and a minimum 50 percent score for APM participants. For additional activities in this category, we propose at § 414.1380 a differentially weighted model for the CPIA performance category with two categories: Medium and high. The justification for these two weights is to provide flexible scoring due to the undefined nature of activities (that is, CPIA standards are not nationally recognized and there is no entity for CPIA that serves the same function as the National Quality Forum does for quality measures). CPIAs are weighted as high based on alignment with CMS national priorities and programs such as the Quality Innovation Network-Quality Improvement Organization (QIN/QIO) or the Comprehensive Primary Care Initiative which recognizes specific activities related to expanded access and integrated behavioral health as important. Programs that require performance of multiple activities such as participation in the Transforming Clinical Practice Initiative, seeing new and follow-up Medicaid patients in a timely manner in the provider's State Medicaid Program, or an activity identified as a public health priority (such as emphasis on anticoagulation management or utilization of prescription drug monitoring programs) were weighted as high.

The statute references patient-centered medical homes as achieving the highest score for the MIPS program. MIPS eligible clinicians or groups may use that to guide them in the criteria or factors that should be taken into consideration to determine whether to weight an activity medium or high on comments for this proposal. We request comments on this proposal, including criteria or factors we should take into consideration to determine whether to weight an activity medium or high.

(c) Submission Criteria

We propose at § 414.1380 to set the CPIA submission criteria under MIPS, in order to achieve the highest potential score of 100 percent, at three high-weighted CPIAs (20 points each) or six medium-weighted CPIAs (10 points each), or some combination of high and medium-weighted CPIAs to achieve a total of 60 points for MIPS eligible clinicians participating as individuals or as groups (refer to Table H of the Appendices for CPIAs and weights). MIPS eligible clinicians or groups that select less than the designated number of CPIAs will receive partial credit based on the weighting of the CPIA selected. To achieve a 50 percent score, one high-weighted and one medium-weighted CPIA or three medium-weighted CPIAs are required for these MIPS eligible clinicians or groups.

Exceptions to the above apply for: MIPS small groups (consisting of 15 or fewer clinicians), MIPS eligible clinicians and groups located in rural areas, MIPS eligible clinicians and groups that are located in geographic HPSAs, non-patient-facing MIPS eligible clinicians or groups or MIPS eligible clinicians, or groups that participate in an APM and/or a patient-centered medical home submitting in MIPS.

For MIPS eligible clinicians and groups that are small, located in rural areas or geographic HPSAs, or non-patient-facing MIPS eligible clinicians or groups, in order to achieve the highest score of 100 percent, two CPIAs are required (either medium or high). Start Printed Page 28211For MIPS eligible clinicians or groups that are small, located in rural areas, located in HPSAs, or non-patient-facing MIPS eligible clinicians or groups, in order to achieve a 50 percent score, one CPIA is required (either medium or high).

MIPS eligible clinicians or groups that participate in APMs are considered eligible to participate under the CPIA performance category unless they are participating in an Advanced APM and they have met the Qualifying APM Participant (QP) thresholds or are Partial QPs that elect not to report information. A MIPS eligible clinician or group that is participating in an APM and participating under the CPIA performance category will receive 50 percent of the total CPIA score (30 points) just through their APM participation. These are MIPS eligible clinicians or groups that CMS identifies as participating in APMs for MIPS and may participate under the CPIA performance category. To achieve 100 percent of the total CPIA score, MIPS eligible clinicians or groups will need to identify that they participate in an alternative payment model (30 points) and also select additional CPIAs for an additional 30 points to reach the 60 point CPIA highest score.

For further description of MIPS eligible clinicians or groups that are required to report to MIPS under the APM scoring standard and their CPIA scoring requirements, we refer readers to section II.E.5.h. For all other MIPS eligible clinicians or groups participating in APMs that would report to MIPS, this section applies and we also refer readers to the scoring requirements for these MIPS eligible clinicians or groups in section II.E.6.

Since we cannot measure variable performance within a single CPIA, we propose at § 414.1380 to compare the CPIA points associated with the reported activities against the highest number of points that are achievable under the CPIA performance category which is 60 points. We propose that the highest potential score of 100 percent can be achieved by selecting a number of activities that will add up to 60 points. MIPS eligible clinicians and groups, including those that are participating as an APM, and all those that select activities under the CPIA performance category can achieve the highest potential score of 60 points by selecting activities that are equal to the 60-point maximum. We refer readers to scoring section II.E.6 for additional rationale for using 60 points for the first year.

If a MIPS eligible clinician or group reports only one CPIA, we will score that activity accordingly, as 10 points for a medium-level activity or 20 points for a high-level activity. If a MIPS eligible clinician or group reports no CPIAs, then the MIPS eligible clinician or group would receive a zero score for the CPIA performance category. We believe this proposal allows us to capture variation in the total CPIAs reported.

In addition, we believe these are reasonable criteria for MIPS eligible clinicians or groups to accomplish within the first year for three reasons: (1) In response to several stakeholder MIPS and APMs RFI comments, we are not recommending a minimum number of hours for performance of an activity; (2) we are offering a broad list of activities from which MIPS eligible clinicians or groups may select; and (3) also in response to MIPS and APMs RFI comments, we are proposing that an activity must be performed for at least 90 days during the performance period for CPIA credit. We intend to reassess this requirement threshold in future years. We do not believe it is appropriate to require a determined number of activities within a specific subcategory at this time. This proposal aligns with the requirements in section 1848(q)(2)(C)(iii) of the Act that states MIPS eligible clinicians or groups are not required to perform activities in each subcategory.

Lastly, we recognize that working with a QCDR could allow a MIPS eligible clinician or group to meet the measure and activity criteria for multiple CPIAs. For the first year of MIPS, there are several CPIAs in the inventory that incorporate QCDR participation. Each activity must be selected and achieved separately for the first year of MIPS. A MIPS eligible clinician or group cannot receive credit for multiple activities just by selecting one activity that includes participation in a QCDR. As the CPIA inventory expands over time we are interested in receiving comments on what restrictions, if any, should be placed around CPIA measures and activities that incorporate QCDR participation.

(d) Required Period of Time for Performing an Activity

We propose § 414.1360 that MIPS eligible clinicians or groups must perform CPIAs for at least 90 days during the performance period for CPIA credit. We understand there are some activities that are ongoing whereas others may be episodic. We considered setting the threshold for the minimum time required for performing an activity to longer periods up to a full calendar year. However, after researching several organizations we believe a minimum of 90 days is a reasonable amount of time. Two illustrative examples of organizations that used 90 days as a window for reviewing clinical practice improvements include practice improvement activities undertaken by anesthesiologists, as detailed in a study describing anesthesiologists' practice improvements as part of the Maintenance of Certification in Anesthesiology Program requiring a 90-day report back period, [10] [11]
and a large Veteran's Administration health care program that set a 90-day window for reviewing improvements in the management of opioid dispensing.[12]

Additional clarification for how some activities meet the 90-day rule or if additional time is required are reflected in the description of that activity in Table H of the Appendices. In addition we propose that activities, where applicable, may be continuing (that is, could have started prior to the performance period and are continuing) or be adopted in the performance period as long as an activity is being performed for at least 90 days during the performance period.

We anticipate in future years that extended CPIA time periods will be needed for certain activities. We will monitor the time period requirement to asses if allowing for extended time requirements may enhance the value associated with generating more effective outcomes, or conversely, the extended time may reveal that more time has little or no value added for certain activities when associated with desired outcomes. We request comments on this proposal.

We understand that non-patient-facing MIPS eligible clinicians and groups may have a limited number of measures and activities to report. Therefore, we propose at § 414.1360 allowing non-patient-facing MIPS eligible clinicians and groups to report on a minimum of one activity to achieve partial credit or two activities to achieve full credit to meet the CPIA submission criteria. These non-patient-facing MIPS eligible clinicians and groups receive Start Printed Page 28212partial or full credit for submitting one or two activities irrespective of any type of weighting, medium or high (for example, two medium activities will qualify for full credit). For scoring purposes, non-patient-facing MIPS eligible clinicians or groups receive 30 points per activity, regardless of whether the activity is medium or high. For example, one high activity and one medium activity could be selected to receive 60 points. Similarly, two medium activities could also be selected to receive 60 points.

We anticipate the number of activities for non-patient-facing MIPS eligible clinicians or groups will increase in future years as we gather more data on the feasibility of performing CPIAs. As part of the process for identifying activities, we consulted with several organizations that represent a cross-section of non-patient-facing MIPS eligible clinicians and groups. An illustrative example of those consulted with include organizations that represent cardiologists involved in nuclear medicine, nephrologists who serve only in a consulting role to other providers, or pathologists who, while they typically function as a team, have different members that perform different roles within their specialty that are primarily non-patient-facing.

In the course of those discussions these organizations identified CPIAs they believed would be applicable. Comments on activities appropriate for non-patient-facing MIPS eligible clinicians or groups are reflected in the proposed CPIA Inventory across multiple subcategories. For example, several of these organizations suggested consideration for Appropriate Use Criteria (AUC). As a result, we have incorporated AUC into some of the activities. We encourage MIPS eligible clinicians or groups who are already required to use AUC (for example, for advanced imaging) to report a CPIA other than one related to appropriate use. Another example, under Patient Safety and Practice Assessment, is the implementation of an antibiotic stewardship program that measures the appropriate use of antibiotics for several different conditions (Upper Respiratory Infection (URI) treatment in children, diagnosis of pharyngitis, bronchitis treatment in adults) according to clinical guidelines for diagnostics and therapeutics. In addition, we request comments on what activities would be appropriate for non-patient-facing MIPS eligible clinicians or groups to add to the CPIA Inventory in the future. We request comments on this proposal.

(5) Special Consideration for Small, Rural, or Health Professional Shortage Areas Practices

As noted previously in this proposed rule, section 1848(q)(2)(B)(iii) of the Act requires the Secretary, in establishing CPIAs, to give consideration to small practices (15 or fewer clinicians) and practices located in rural areas (proposed definition at § 414.1305) and in geographic based HPSAs as designated under section 332(a)(1)(A) of the Public Health Service Act. In the MIPS and APMs RFI, we requested comments on how CPIAs should be applied to MIPS eligible clinicians or groups in small practices, in rural areas, and geographic HPSAs: If a lower performance requirement threshold or different measures should be established that will better allow those MIPS eligible clinicians or groups to perform well in this performance category, what methods should be leveraged to appropriately identify these practices, and what best practices should be considered to develop flexible and adaptable CPIAs based on the needs of the community and its population.

We engaged high performing organizations, including several rural health clinics with 15 or fewer clinicians that are designated as geographic HPSAs, to provide feedback on relevant QIN/QIO activities based on their specific circumstances. Some examples provided include participation in implementation of self-management programs such as for diabetes, and early use of telemedicine, as in the one case for a top performing multi-specialty rural practice that covers 20,000 people over a 25,000-mile radius in a rural area of North Dakota. Comments on activities appropriate for MIPS eligible clinicians or groups located in rural areas or practices that are designated as geographic HPSAs are reflected in the proposed CPIA Inventory across multiple subcategories.

Based on the review of comments and listening sessions, we propose at § 414.1360 to accommodate small practices and practices located in rural areas, or geographic HPSAs for the CPIA performance category by allowing MIPS eligible clinicians or groups to submit a minimum of one activity to achieve partial credit or two activities to achieve full credit. These MIPS eligible clinicians or groups receive partial or full credit for submitting two activities of any type of weighting (for example, two medium activities will qualify for full credit). We anticipate the requirement on the number of activities for small practices and practices located in rural areas, or practices in geographic HPSAs will increase in future years as we gather more data on the feasibility of small practices and practices located in rural areas and practices located in geographic HPSAs to perform CPIAs. Therefore, we request comments on what activities would be appropriate for these practices for the CPIA Inventory in future years. We request comments on this proposal.

(6) CPIA Subcategories

Section 1848(q)(2)(B)(iii) of the Act provides that the CPIA performance category must include at least the subcategories listed below. The statute also provides the Secretary discretion to specify additional subcategories for the CPIA performance category, which have also been included below.

Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.

Population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR.

Care coordination, such as timely communication of test results, timely exchange of clinical information to patients and other MIPS eligible clinicians or groups, and use of remote monitoring or telehealth.

Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision-making mechanisms.

Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.

Participation in an APM, as defined in section 1833(z)(3)(C) of the Act.

In the MIPS and APMs RFI, we requested recommendations on the inclusion of the following five potential new subcategories:

Social and Community Involvement, such as measuring Start Printed Page 28213completed referrals to community and social services or evidence of partnerships and collaboration with the community and social services.

Achieving Health Equity, as its own performance category or as a multiplier where the achievement of high quality in traditional areas is rewarded at a more favorable rate for MIPS eligible clinicians or groups that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs.

Emergency preparedness and response, such as measuring MIPS eligible clinician or group participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty military MIPS eligible clinician or group activities, and measuring MIPS eligible clinician or group volunteer participation in domestic or international humanitarian medical relief work.

Integration of primary care and behavioral health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; or cross-training of MIPS eligible clinicians or groups participating in integrated care. This subcategory also includes integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.

We recognize that quality improvement is a critical aspect of improving the health of individuals and the health care delivery system overall. We also recognize that this will be the first time MIPS eligible clinicians or groups will be measured on the quality improvement work on a national scale. We have approached the CPIA performance category with these principles in mind along with the overarching principle for the MIPS program that we are building a process that will have increasingly more stringent requirements over time.

Therefore, for the first year of MIPS, we propose at § 414.1365 that the CPIA performance category include the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. In addition, we propose at § 414.1365 adding the following subcategories: “Achieving Health Equity”, “Integrated Behavioral and Mental Health”, and “Emergency Preparedness and Response.” In response to multiple MIPS and APMs RFI comments requesting the inclusion of “Achieving Health Equity,” we are proposing to include this subcategory because: (1) It is important and may require targeted effort to achieve and so should be recognized when accomplished; (2) supports our national priorities and programs, such as Reducing Health Disparities; and (3) encourages “use of plans, strategies, and practices that consider the social determinants that may contribute to poor health outcomes.” (CMS, Quality Innovation Network Quality Improvement Organization Scope of Work: Excellence in Operations and Quality Improvement, 2014).

Similarly, MIPS and APMs RFI comments strongly supported the inclusion of the subcategory of “Integrated Behavioral and Mental Health”, citing that “statistics show 50 percent of all behavioral health disorders are being treated by primary care and behavioral health integration.” Additionally, according to MIPS and APMs RFI comments, behavioral health integration with primary care is already being implemented in numerous locations throughout the country. The third additional subcategory we propose to include is “Emergency Preparedness and Response,” based on MIPS and APMs RFI comments that encouraged us to consider this subcategory to help ensure that practices remain open during disaster and emergency situations and support emergency response teams as needed. Additionally, commenters were able to provide a sufficient number of recommended activities (that is, more than one) that could be included in the CPIA Inventory in all of these proposed subcategories and the subcategories included under section 1848(q)(2)(B)(iii) of the Act.

We also seek public comments on two additional subcategories for future consideration:

Promoting Health Equity and Continuity, including (a) serving Medicaid beneficiaries, including individuals dually eligible for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries, (c) participating in the network of plans in the Federally Facilitated Marketplace or state exchanges, and (d) maintaining adequate equipment and other accommodations (for example, wheelchair access, accessible exam tables, lifts, scales, etc.) to provide comprehensive care for patients with disabilities; and

Social and Community Involvement, such as measuring completed referrals to community and social services or evidence of partnerships and collaboration with community and social services.

For these two subcategories, we are requesting activities that can demonstrate some improvement over time and go beyond current practice expectations. For example, maintaining existing medical equipment would not qualify for a CPIA, but implementing some improved clinical workflow processes that reduce wait times for patients with disabilities or improve coordination of care including activities that regularly provide additional assistance to find other care needed for patients with disabilities, would be some examples of activities that could show improvement in clinical practice over time.

We request comments on these proposals.

(7) CPIA Inventory

To implement the MIPS program, we are required to create an inventory of CPIAs. Consistent with our MIPS strategic goals, we believe it is important to create a broad list of activities that can be used by multiple practice types to demonstrate CPIAs and activities that may lend themselves to being measured for improvement in future years.

We took several steps to ensure the initial CPIA Inventory is inclusive of activities in line with the statutory intent. We had numerous interviews with highly performing organizations of all sizes, conducted an environmental scan to identify existing models, activities, or measures that met all or part of the CPIA category, including the patient centered medical homes, the Transforming Clinical Practice Initiative (TCPI), Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys, and AHRQ's Patient Safety Organizations. In addition, we reviewed the CY 2016 PFS final rule with comment period (80 FR 70886) and the comments received in response to the MIPS and APMs RFI regarding the CPIA performance category. The CPIA Inventory was compiled as a result of the stakeholder input, an environmental scan, MIPS and MIPS and APMs RFI comments, and subsequent working sessions with AHRQ and ONC and additional communications with CDC, SAMHSA and HRSA.

Based on the above discussions we established guidelines for CPIA inclusion based on one or more of the following criteria (in any order):

Feasible to implement, recognizing importance in minimizing burden, especially for small (15 or fewer clinicians) practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;

CMS is able to validate the activity; or

Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes.

Activities that overlap with other performance categories were excluded unless there was a strong policy rationale to include it in the CPIA Inventory. We propose to use the CPIA Inventory for the first year of MIPS, as provided in Table H of the Appendices. For further description of how MIPS eligible clinicians or groups will be designated to submit to MIPS for CPIA, we refer readers to section II.E.6.h. For all other MIPS eligible clinicians or groups participating in APMs that would report to MIPS, this section applies and we also refer readers to the scoring requirements for these MIPS eligible clinicians or groups in section II.E.5. of this proposed rule.

We request comments on the inventory and welcome suggestions for CPIAs for future years as well.

(a) CMS Study on CPIA and Measurement

(1) Study Purpose

From our experience under the PQRS, VM, and Medicare EHR Incentive programs we have discovered that many providers have errors within their data sets, as well as issues understanding the data that corresponds to their selected quality measures. To help better understand the current processes and limitations, we propose to conduct a study on CPIAs and measurement to examine clinical quality workflows and data capture using a simpler approach to quality measures. The study will allow a limited number of selected MIPS eligible clinicians and groups to receive full credit (60 points) for the CPIA category.

The lessons learned in this study on practice improvement and measurement may or may not influence changes to future MIPS data submission requirements. The goals of the study are to see whether there will be improved outcomes, reduced burden in reporting, and enhancements in clinical care by selected MIPS eligible clinicians desiring:

A more data driven approach to quality measurement.

Measure selection unconstrained with a CEHRT program or system.

Improving data quality submitted to CMS.

Enabling CMS get data more frequently and provide feedback more often.

(2) Study Participation Credit and Requirements

Eligible clinicians and groups in the CMS study on practice improvement and measurement will receive full credit for the CPIA category of MIPS after successfully electing, participating and submitting data to CMS. Based on feedback and surveys from MIPS eligible clinicians, study measurement data will be made available to CMS throughout the study on at least a quarterly basis unless the MIPS eligible clinician or group agrees to submit data on a more frequent basis. Participants will be required to attend a monthly focus group to share lessons learned along with providing survey feedback to monitor effectiveness. The focus group will also include providing visual displays of data, workflows, and best practices to be shared amongst the participants to obtain feedback and make further improvements. The monthly focus groups will be used to learn from the practices on how to be more agile as we test new ways of measure recording and workflow.

For the 2017 performance period, the participating MIPS eligible clinicians or groups would submit their data and workflows for a minimum of three MIPS clinical quality measures that are relevant and prioritized by their practice. One of the measures must be an outcome measure, and one must be a patient experience measure. The participating MIPS eligible clinicians could elect to report on more measures as this would provide more options from which to select in subsequent years for purposes of measuring improvement.

If MIPS eligible clinicians or groups calculate the measures working with a QCDR, qualified registry, or CMS-approved third party intermediary, CMS will use the same data validation process described in section II.E.8.e. CMS will only collect the numerator and denominator for the measures selected for the overall population, all patients/all payers. This will enable the practices to build the measures based on what is important for their area of practice while increasing the quality of care.

In future years, participating MIPS eligible clinicians or groups would select three of the measures for which they have baseline data from the 2017 performance period to compare against later performance years. Participants electing to continue in future years will be afforded the opportunity opt-in or opt-out following the successful submission of data to CMS. The first opportunity to continue in the study will be at the end of the 2017 performance period. Eligible clinicians who elect to join the study but fail to participate and/or fail to successfully submit the data required will be removed from the study. Unsuccessful study participants will then be subject to the full requirements for the CPIA category.

(3) Study Participation Eligibility

Participation will be open to a limited number of MIPS eligible clinicians in rural settings and non-rural settings. A rural area is defined at § 414.1305 and a non-rural area would be any MIPS eligible clinicians or groups not included as part of the rural definition. This test will be open to include up to 10 non-rural individual MIPS eligible clinicians or groups of less than three non-rural MIPS eligible clinician's, 10 rural individual MIPS eligible clinicians or groups of less than three rural MIPS eligible clinician's, 10 groups of three to eight MIPS eligible clinicians, five groups of nine to twenty MIPS eligible clinicians, three groups of twenty-one to one hundred MIPS eligible clinicians, two groups of greater than 100 MIPS eligible clinicians, and two specialist groups of MIPS eligible clinicians. Eligible clinicians and groups will need to sign up from January 1, 2017, to January 31, 2017. The sign up process will utilize this web-based interface— http://oncprojectracking.org/​. Participants will be approved on a first come first served basis and must meet all the required criteria.

We request comment on the study and welcome suggestions on future study topics.

(8) CPIA Policies for Future Years of the MIPS Program

(a) Proposed Approach for Identifying New Subcategories and New Activities

We propose, for future years of, MIPS, to consider the addition of a new subcategory or activity to the CPIA Start Printed Page 28215Inventory only when the following criteria are met:

The new subcategory represents an area that could highlight improved beneficiary health outcomes, patient engagement and safety based on evidence.

The new subcategory has a designated number of activities that meet the criteria for a CPIA activity and cannot be classified under the existing subcategories.

Newly identified subcategories would contribute to improvement in patient care practices or improvement in performance on quality measures and resource use performance categories.

In future years, MIPS eligible clinicians or groups will have an opportunity to nominate additional subcategories, along with activities associated with each of those subcategories that are based on criteria specified for these activities, as discussed above.

We request comments on this proposal.

(b) Request for Comments on Call for Measures and Activities Process for Adding New Activities and New Subcategories

We plan to develop a call for measures and activities process for future years of MIPS, where MIPS eligible clinicians or groups and other relevant stakeholders may recommend activities for potential inclusion in the CPIA Inventory. As part of the process, MIPS eligible clinicians or groups would be able to nominate additional activities that we could consider adding to the CPIA Inventory. The MIPS eligible clinician or group or relevant stakeholder would be able to provide an explanation of how the activity meets all the criteria we have identified. This nomination and acceptance process would, to the best extent possible, parallel the annual call for measures process already conducted by CMS for quality measures. The final CPIA Inventory for the performance year would be published in accordance with the overall MIPS rulemaking timeline and program. In addition, in future years we anticipate developing a process and establishing criteria to remove or add new activities to CPIA.

Additionally, prospective activities that are submitted through a QCDR could also be included as part of a beta-test process that may be instrumental for future years to determine whether that activity should be included in the CPIA Inventory based on specific criteria noted above. MIPS eligible clinicians or groups and groups that use QCDRs to capture data associated with an activity, for example the frequency in administering depression screening and a follow-up plan, may be asked to voluntarily submit that same data in year 2 to begin identifying a baseline for improvement for subsequent year analysis. This is not intended to require any MIPS eligible clinician or group to submit CPIAs only via QCDR from one year to the next or to require the same activity from one year to the next. Participation in doing so, however, can help to identify how activities can contribute to improve outcomes. This data submission process will be considered part of a beta-test to: (1) Determine if the activity is being regularly conducted and effectively executed and (2) if the activity warrants continued inclusion on the CPIA Inventory. The data will help capture baseline information to begin measuring improvement and inform the Secretary of the likelihood that the activity would result in improved outcomes. If an activity is submitted and reported by a QCDR, it would be reviewed by CMS for final inclusion in the CPIA Inventory the following year, even if these activities are not submitted through the future call for measures and activities process. We intend, in future performance years, to begin measuring CPIA data points for all eligible clinicians and to award scores based on performance and improvement. We solicit comment on how best to collect such CPIA data and factor it into future scoring under MIPS.

We request comments on this approach and on any other considerations we should take into account when developing this type of approach for future rulemaking.

(c) Request for Comments on Use of QCDRs for Identification and Tracking of Future Activities

In future years, we expect to learn more about CPIAs and how the inclusion of additional measures and activities captured by QCDRs could enhance the ability of MIPS eligible clinicians or groups to capture and report on more meaningful activities. This is especially true for specialty groups. In the future, we may propose use of QCDRs for identification and acceptance of additional measures and activities which is in alignment with section 1848(q)(1)(E) of the Act which encourages the use of QCDRs, as well as under section 1848(q)(2)(B)(iii)(II) of the Act related to the population management subcategory. We recognize, through the MIPS and APMs RFI comments and interviews with organizations that represent non-patient-facing MIPS eligible clinicians or groups and specialty groups that QCDRs may provide for a more diverse set of measures and activities under CPIA than are possible to list under the current CPIA Inventory. This diverse set of measures and activities, which we can validate, affords specialty practices additional opportunity to report on more meaningful activities in future years. QCDRs may also provide the opportunity for longer-term data collection processes which will be needed for future year submission on improvement, in addition to achievement. Use of QCDRs also supports ongoing performance feedback and allows for implementation of continuous process improvements. We believe that for future years, QCDRs will be allowed to define specific CPIAs for specialty and non-patient-facing MIPS eligible clinicians or groups through the already-established QCDR approval process for measures and activities. We request comments on this approach.

g. Advancing Care Information Performance Category

(1) Background and Relationship to Prior Programs

(a) Background

The American Recovery and Reinvestment Act of 2009 (ARRA), which included the Health Information Technology for Economic and Clinical Health Act (HITECH Act), amended Titles XVIII and XIX of the Act to authorize incentive payments and Medicare payment adjustments for EPs to promote the adoption and meaningful use of certified EHR technology (CEHRT). Section 1848(o) of the Act provides the statutory basis for the Medicare incentive payments made to meaningful EHR users. Section 1848(a)(7) of the Act also establishes downward payment adjustments, beginning with calendar year (CY) 2015, for EPs who are not meaningful users of certified EHR technology for certain associated EHR reporting periods. (For a more detailed explanation of the statutory basis for the Medicare and Medicaid EHR Incentive Programs, see the July 28, 2010 Stage 1 final rule titled, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule” (75 FR 44316 through 44317).)

A primary policy goal of the EHR Incentive Program is to encourage and promote the adoption and use of certified EHR technology among Medicare and Medicaid health care providers to help drive the industry as a whole toward the use of certified EHR technology. As described in the final rule titled “Medicare and Medicaid Start Printed Page 28216Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 Through 2017” (Hereinafter referred to as the “2015 EHR Incentive Programs Final Rule”) (80 FR 62769), the HITECH Act outlined several foundational requirements for meaningful use and for EHR technology. CMS and ONC have subsequently outlined a number of key policy goals which are reflected in the current objectives and measures of the program and the related certification requirements (80 FR 62790). Current Medicare EP performance on these key goals is varied, with EPs demonstrating high performance on some objectives while others represent a greater challenge.

(b) MACRA Changes

Section 1848(q)(2)(A) of the Act, as added by section 101(c) of the MACRA, includes the meaningful use of certified EHR technology as a performance category under the MIPS, referred to in this proposed rule as the advancing care information performance category, which will be reported by MIPS eligible clinicians as part of the overall MIPS program. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories shall be used in determining the MIPS CPS for each MIPS eligible clinician. In general, MIPS eligible clinicians will be evaluated under all four of the MIPS performance categories, including the advancing care information performance category. This includes MIPS eligible clinicians who were not previously eligible for the EHR Incentive Program incentive payments under section 1848(o) of the Act or subject to the EHR Incentive Program payment adjustments under section 1848(a)(7) of the Act, such as physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and hospital-based EPs (as defined in section 1848(o)(1)(C)(ii) of the Act). Understanding that these MIPS eligible clinicians may not have prior experience with certified EHR technology and the objectives and measures under the EHR Incentive Program, we have proposed a scoring methodology within the advancing care information performance category that provides flexibility for MIPS eligible clinicians from early adoption of certified EHR technology through advanced use of health IT. We note that in section II.e.5.g.8.a of this proposed rule, we have also proposed to reweight the advancing care information performance category to zero in the MIPS composite performance score for certain hospital-based and other MIPS eligible clinicians where the measures proposed for this performance category may not be available or applicable to these types of MIPS eligible clinicians.

In implementing MIPS, we intend to develop the requirements for the advancing care Information performance category to continue supporting the foundational objectives of the HITECH Act, and to encourage continued progress on key uses such as health information exchange and patient engagement. These more challenging objectives are essential to leveraging certified EHR technology to improve care coordination and they represent the greatest potential for improvement and for significant impact on delivery system reform in the context of MIPS quality reporting.

In developing the requirements and structure for the advancing care information performance category, we considered several approaches for establishing a framework that would naturally integrate with the other MIPS performance categories. We considered historical performance on the EHR Incentive Program objectives and measures, feedback received through public comment, and the long term goals for delivery system reform and quality improvement strategies.

One approach we considered would be to maintain the current structure of the Medicare EHR Incentive Program and award full points for the advancing care information performance category for meeting all of the objectives and measures finalized in the 2015 EHR Incentive Programs final rule, and award zero points for failing to meet all of these requirements. This method would be consistent with the current EHR Incentive Program and is based on objectives and measures already established in rulemaking. However, we considered and dismissed this approach as it would not allow flexibility for MIPS eligible clinicians and would not allow CMS to effectively measure performance for MIPS eligible clinicians in the advancing care information performance category who have taken incremental steps toward the use of certified EHR technology, or to recognize exceptional performance for MIPS eligible clinicians who have excelled in any one area. This is particularly important as many MIPS eligible clinicians may not have had past experience relevant to the advancing care information performance category and use of EHR technology because they were not previously eligible to participate in the Medicare EHR Incentive Program. This approach also does not allow for differentiation among the objectives and measures that have high adoption and those where there is potential for continued advancement and growth.

We subsequently considered several methods which would allow for more flexibility and provide CMS the opportunity to recognize partial or exceptional performance among MIPS eligible clinicians for the measures under the advancing care information performance category. We decided to design a framework that would allow for flexibility and multiple paths to achievement under this category while recognizing MIPS eligible clinicians' efforts at all levels. Part of this framework requires moving away from the concept of requiring a single threshold for a measure, and instead incentivizes continuous improvement, and recognizes onboarding efforts among late adopters and MIPS eligible clinicians facing continued challenges in full implementation of certified EHR technology in their practice.

(2) Advancing Care Information Performance Category Within MIPS

In defining the advancing care information performance category for the MIPS, we considered stakeholder feedback and lessons learned from our experience with the Medicare EHR Incentive Program. Specifically, we considered feedback from the Stage 1 (75 FR 44313) and Stage 2 (77 FR 53967) EHR Incentive Program rules, and the 2015 EHR Incentive Programs final rule (80 FR 62769), as well as comments received from the MIPS and APMs RFI (80 FR 59102). We have learned from this feedback that clinicians desire flexibility to focus on health IT implementation that is right for their practice. We have also learned that updating software, training staff and changing practice workflows to accommodate new technology can take time, and that clinicians need time and flexibility to focus on the health IT activities that are most relevant to their patient population. Clinicians also desire consistent timelines and reporting requirements in order to simplify and streamline the reporting process. Recognizing this, we have worked to align the advancing care information performance category with the other MIPS performance categories, which would streamline reporting requirements, timelines and measures in an effort to reduce burden on MIPS eligible clinicians.Start Printed Page 28217

The implementation of the advancing care information performance category is an important opportunity to increase clinician and patient engagement, improve the use of health IT to achieve better patient outcomes, and continue to meet the vision of enhancing the use of certified EHR technology as defined under the HITECH Act. As discussed later in this section, we are proposing in section II.E.5.g.6.a. new flexibility in how we would assess MIPS eligible clinician performance for the advancing care information performance category. We propose to emphasize performance in the objectives and measures that are the most critical and would lead to the most improvement in the use of health IT and health care quality. We intend to promote innovation so that technology can be interconnected easily and securely, and data can be accessed and directed where and when it is needed to support patient care. These objectives include Patient Electronic Access, Coordination of Care Through Patient Engagement and Health Information Exchange, which are essential to leveraging certified EHR technology to improve care. At the same time, we propose to eliminate reporting on objectives and measures in which the vast majority of clinicians already achieve high performance—which would reduce burden, encourage greater participation and direct MIPS eligible clinicians' attention to higher-impact measures. Our proposal balances program participation with rewarding performance on high-impact objectives and measures, which we believe would make the overall program stronger and further the goals of the HITECH Act.

(a) Advancing the Goals of the HITECH Act in MIPS

Section 1848(o)(2)(A) of the Act requires that the Secretary seek to improve the use of electronic health records and health care quality over time by requiring more stringent measures of meaningful use. In implementing MIPS and the advancing care information performance category, we seek to improve and encourage the use of certified EHR technology over time by adopting a new, more flexible scoring methodology, as discussed in section II.E.5.g.6. of this proposed rule, that would more effectively allow MIPS eligible clinicians to reach the goals of the HITECH Act, and would allow MIPS eligible clinicians to use EHR technology in a manner more relevant to their practice. This new, more flexible scoring methodology puts a greater focus on Patient Electronic Access, Coordination of Care Through Patient Engagement, and Health Information Exchange—objectives we believe are essential to leveraging certified EHR technology to improve care by engaging patients and furthering interoperability. This methodology would also de-emphasize objectives in which clinicians have historically achieved high performance with median performance rates of over 90 percent for the last 2 years. We believe shifting focus away from these objectives would reduce burden, encourage greater participation, and direct attention to other objectives and measures which require more attention. Through this flexibility, MIPS eligible clinicians would be incentivized to focus on those aspects of certified EHR technology that are most relevant to their practice, which we believe would lead to improvements in health care quality.

We also seek to increase the adoption and use of certified EHR technology by incorporating such technology into the other MIPS performance categories. For example, in section II.6.a.2.f. of this proposed rule, we are proposing to incentivize electronic reporting by awarding a bonus point for submitting quality measure data using certified EHR technology. Additionally, in section II.E.5.f. of this proposed rule, we have aligned some of the activities under the CPIA performance category such as Care Coordination, Beneficiary Engagement and Achieving Health Equity with a focus on enhancing the use of certified EHR technology. We believe this approach would strengthen the adoption and use of EHR systems and program participation consistent with the provisions of section 1848(o)(2)(A) of the Act.

(b) Future Considerations

We note that the increased flexibility and removal of previously established thresholds for reporting, as proposed in this section of this proposed rule, may appear to be a lower standard than what previously existed in the Medicare EHR Incentive Program. In reality, this restructuring of program requirements is geared toward increasing participation and EHR adoption. We believe this is the most effective way to encourage the adoption of certified EHR technology, and introduce new MIPS eligible clinicians to the use of EHR technology and health IT overall.

We will continue to review and evaluate MIPS eligible clinician performance in the advancing care information performance category, and will consider evolutions in health IT over time as it relates to this performance category. Based on our ongoing evaluation, we expect to adopt changes to the scoring methodology for the advancing care information performance category to ensure the efficacy of the program and to ensure increased value for MIPS eligible clinicians, as well as to adopt more stringent measures of meaningful use as required by section 1848(o)(2)(A) of the Act.

Potential changes may include establishing benchmarks for MIPS eligible clinician performance on the advancing care information performance category measures, and using these benchmarks as a baseline or threshold for future reporting. This may include scoring for performance improvement over time and the potential to reevaluate the efficacy of measures based on these analyses. For example, in future years we may use a MIPS eligible clinician's prior performance on the advancing care information performance category measures as comparison for the subsequent year's performance category score, or compare a MIPS eligible clinician's performance category score to peer groups to measure their improvement and determine a performance category score based on improvement over those benchmarks or peer group comparisons. This type of approach would drive continuous improvement over time through the adoption of more stringent performance standards for the advancing care information performance category measures.

We are committed to continual review, improvement and increased stringency of the advancing care information performance category measures as directed under section 1848(o)(2)(A) of the Act both for the purposes of ensuring program efficacy as well as ensuring value for the MIPS eligible clinicians reporting the advancing care information performance category measures. We seek comment on further methods to increase the stringency of the advancing care information performance category measures in the future.

We additionally seek comment on the concept of a holistic approach to health IT—one that we believe is similar to the concept of outcome measures in the quality performance category in the sense that MIPS eligible clinicians could potentially be measured more directly on how the use of health IT contributes to the overall health of their patients. Under this concept, MIPS eligible clinicians would be able to track certain use cases or patient outcomes to tie patient health outcomes with the use of health IT.

We believe this approach would allow us to directly link health IT adoption and use to patient outcomes, moving Start Printed Page 28218MIPS beyond the measurement of EHR adoption and process measurement and into a more patient-focused health IT program. From comments and feedback we have received from the health care provider community, we understand that this type of approach would be a welcome enhancement to the measurement of health IT. At this time, we recognize that technology and measurement for this type of program is currently unavailable. We seek comment on what this type of measurement would look like under MIPS, including the type of measures that would be needed within the advancing care information performance category and the other performance categories to measure this type of outcome, what functionalities with certified EHR technology would be needed, and how such an approach could be implemented.

(3) Clinical Quality Measurement

Section 1848(o)(2)(A)(iii) of the Act requires the reporting of clinical quality measures (CQMs) using certified EHR technology. Section 1848(q)(5)(B)(ii)(II) provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall, with respect to a performance period for a year, for which a MIPS eligible clinician reports applicable measures under the quality performance category through the use of certified EHR technology, treat the MIPS eligible clinician as satisfying the CQMs reporting requirement under section 1848(o)(2)(A)(iii) of the Act for such year. We note that in the context and overall structure of MIPS, the quality performance category allows for a greater focus on patient-centered measurement, and multiple pathways for MIPS eligible clinicians to report their quality measure data. Therefore, we are not proposing separate requirements for clinical quality measure reporting within the advancing care information performance category and instead would require submission of quality data for measures specified for the quality performance category, in which we encourage reporting of CQMs with data captured in certified EHR technology. We refer readers to section II.E.5.a of this proposed rule for discussion of reporting of CQMs with data captured in certified EHR technology under the quality performance category.

In the Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 proposed rule, we proposed to eliminate the 90-day EHR reporting period beginning in 2017 for EPs who had not previously demonstrated meaningful use, with a limited exception for the Medicaid EHR Incentive Program (80 FR 16739-16740, 16774-16775). We received many comments from respondents stating their preference for maintaining the 90-day EHR reporting period to allow first time participants to avoid payment adjustments. In addition, commenters indicated that the 90-day time period reduced administrative burden and allowed for needed time to adapt their EHRs to ensure they could achieve program objectives. As a result, we did not finalize our proposal and established a 90-day EHR reporting period for all EPs in 2015 and for new participants in 2016, as well as a 90-day EHR reporting period for new participants in 2015, 2016, and 2017 with regard to the payment adjustments (80 FR 62777-62779; 62904-62906).

Moving forward, the implementation of MIPS creates a critical opportunity to align performance periods to ensure that quality, CPIA, resource use, and the advancing care information performance categories are all measured and scored based on the same period of time. We believe this would lower reporting burden, focus clinician quality improvement efforts and align administrative actions so that clinicians can use common systems and reporting pathways.

Under MIPS, we propose to align the performance period for the advancing care information performance category to the proposed MIPS performance period of one full calendar year. Thus, the performance period for the advancing care information performance category would be the same as the performance periods for the other performance categories as indicated in section II.E.4. We note that there would not be a separate 90-day performance period for the advancing care information performance category. Under this proposal, MIPS eligible clinicians would need to submit data based on performance period starting January 1, 2017, and ending December 31, 2017 for the first year of MIPS. We recognize that stakeholders may still have concerns related to a full year performance period. We note that, as discussed in section II.E.4. of this proposed rule, MIPS eligible clinicians that only have data for a portion of the year can still submit data, be assessed and be scored for the advancing care information performance category. Under the proposal, MIPS eligible clinicians would need to possess certified EHR technology and report on the objectives and measures (without meeting any thresholds) during the calendar year performance period to achieve the advancing care information category base score. We note that MIPS eligible clinicians would be required to submit all of the data they have available for the performance period, even if the time period they have data for is less than one full calendar year.

We believe this proposal would reduce reporting burden and streamline requirements so that MIPS eligible clinicians and third party intermediaries, such as registries and QCDRs, would have a common timeline for data submission to all performance categories. We refer readers to section II.E.4. of this proposed rule for discussion of the performance period for MIPS and solicit feedback on our proposal.

(a) Definition of Meaningful EHR User and Certification Requirements

The use of certified health IT continues to be an important component of care delivery for clinicians. Certified health IT that advances patient engagement, interoperability, and privacy and security are key to care coordination, and a critical component in improving health outcomes.

We anticipate that as certified health IT and related standards continue to evolve to support health information exchange, care coordination (for example, referral management), and other capabilities, we will consider updates to the certified health IT requirements for MIPS. We continue to work with the Office of the National Coordinator for Health IT to identify certified health IT that would aid clinicians in MIPS.

Throughout this proposed rule, we use the terms “certified health IT” and “certified EHR technology”. These terms refer to health information technologies and systems that are certified to various standards and functions under the ONC Health IT Certification Program. In general, the full range of potential technologies, functions, standards, and systems for which ONC has established certification criteria are referred to as “certified health IT” (See the 2015 Edition Health IT Certification Criteria final rule (80 FR 62604)). In contrast, the term “certified EHR technology” is a statutory and regulatory term that defines the technology that MIPS eligible clinicians Start Printed Page 28219and participants in Advanced APMs must use.

It is important to note that certified EHR technology is a part of the larger category of certified health IT. Therefore when discussing certified health IT in a broad and general manner; such a discussion includes both the functions included in certified EHR technology and other additional potential functions and criteria. In other words, certified EHR technology is a subset of the broader definition of certified health IT.

“Certified health IT” is used in two different ways within this proposed rule. The first is stated as “certified health IT” to identify where the text is referencing a broad range of technology that is included in the ONC Health IT Certification Program. The second use is where the term “a certified Health IT Module” identifies a technology or function used independently from the clinicians' EHR. An example of this second use of the term includes the certified functions leveraged by Health Information Exchange organizations, QCDRs, and public health agencies to support actions like information exchange, quality measurement, and data submission. These individual functions may also be a part of the certified EHR technology definition and may connect with the EHR, but are in these cases used independently from the clinicians' EHR systems.

ONC and CMS worked closely to identify the set of certified health IT that are part of the certified EHR technology definitions proposed in this rule. For example, ONC's 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications (80 FR 62602 through 62759) hereinafter referred to as “2015 Edition final rule”, defines the technological requirements for health IT systems used by EHR Incentive Program participants. In this proposed rule, we are proposing to adopt a definition of certified EHR technology at § 414.1305 for MIPS eligible clinicians that is based on the definition that applies in the EHR Incentive Programs under 42 CFR 495.4.

In the 2015 EHR Incentive Programs final rule (80 FR 62873) we outlined the requirements for EPs using certified EHR technology in 2017 as it relates to the objectives and measures they select to report. We propose at § 414.1375 similar requirements for the use of certified EHR technology in relation to the selection of objectives and measures under the MIPS advancing care information performance category.

For 2017, the first MIPS performance period, MIPS eligible clinicians would be able to use EHR technology certified to either the 2014 or 2015 Edition certification criteria as follows:

A MIPS eligible clinician who only has technology certified to the 2015 Edition may choose to report: (1) On the objectives and measures specified for the advancing care information performance category in section II.E.5.g.7 of this proposed rule, which correlate to Stage 3 requirements; or (2) on the alternate objectives and measures specified for the advancing care information performance category in section II.E.5.g.7 of this proposed rule, which correlate to modified Stage 2 requirements.

A MIPS eligible clinician who has technology certified to a combination of 2015 Edition and 2014 Edition may choose to report: (1) On the objectives and measures specified for the advancing care information performance category in section II.E.5.g.7 of this proposed rule, which correlate to Stage 3; or (2) on the alternate objectives and measures specified for the advancing care information performance category as described in section II.E.5.g.7 of this proposed rule, which correlate to modified Stage 2, if they have the appropriate mix of technologies to support each measure selected.

A MIPS eligible clinician who only has technology certified to the 2014 Edition would not be able to report on any of the measures specified for the advancing care information performance category described in section II.E.5.g.7 of this proposed rule that correlate to a Stage 3 measure that requires the support of technology certified to the 2015 Edition. These MIPS eligible clinicians would be required to report on the alternate objectives and measures specified for the advancing care information performance category as described in section II.E.5.g.7. of this proposed rule, which correlate to modified Stage 2 objectives and measures.

Beginning with the performance period in 2018, MIPS eligible clinicians:

Must only use technology certified to the 2015 Edition to meet the objectives and measures specified for the advancing care information performance category in section II.E.5.g.7. of this proposed rule, which correlate to Stage 3.

We welcome comments on this proposal, which is intended to maintain consistency across MIPS, the Medicare EHR Incentive Program and the Medicaid EHR Incentive Program.

Finally, we propose to define at § 414.1305 a meaningful EHR user under MIPS as a MIPS eligible clinician who possesses certified EHR technology, uses the functionality of certified EHR technology, and reports on applicable objectives and measures specified for the advancing care information performance category for a performance period in the form and manner specified by CMS.

We invite comments on our proposals.

(b) Method of Data Submission

Under the Medicare EHR Incentive Program, EPs attest to the numerators and denominators for certain objectives and measures, through a CMS web portal. For the purpose of reporting advancing care information performance category objectives and measures under the MIPS, we propose at § 414.1325 to allow for MIPS eligible clinicians to submit advancing care information performance category data through qualified registry, EHR, QCDR, attestation and CMS Web Interface submission methods. Regardless of data submission method, all MIPS eligible clinicians must follow the reporting requirements for the objectives and measures to meet the requirements of the advancing care information performance category.

We note that under this proposal, 2017 would be the first year that EHRs (through the QRDA submission method), QCDRs and qualified registries would be able to submit EHR Incentive Program objectives and measures (as adopted for the advancing care information performance category) to CMS, and the first time this data would be reported through the CMS Web Interface. We recognize that some Health IT vendors, QCDRs and qualified registries may not be able to conduct this type of data submission for the 2017 performance period given that the development efforts associated with this data submission capability. However, we are including these data submission mechanisms in 2017 to support early adopters and to signal our longer-term commitment to working with organizations that are agile, effective and can create less burdensome data submission mechanisms for MIPS eligible clinicians. We believe the proposed data submission methods could reduce reporting burden by synchronizing reporting requirements and data submission, and systems, allow for greater access and ease in submitting data throughout the MIPS program. We note that specific details about the form and manner for data submission will be addressed by CMS in the future.Start Printed Page 28220

(c) Group Reporting

Under the Medicare EHR Incentive Program, CMS adopted a reporting mechanism for EPs that are part of a group to attest using one common form, or batch reporting process. Under that batch reporting process CMS assessed the individual performance of the EPs that made up the group, not the group as a whole, to determine whether those EPs meaningfully used certified EHR technology.

The structure of the MIPS and our desire to achieve alignment across the MIPS performance categories appropriately necessitates the ability to assess the performance of MIPS eligible clinicians at the group level for all MIPS performance categories. We believe MIPS eligible clinicians should be able to submit data as a group, and be assessed at the group level, for all of the MIPS performance categories, including the advancing care information performance category. For this reason, we are proposing a group reporting mechanism for individual MIPS eligible clinicians to have their performance assessed as a group for all performance categories in section II.E.1.e. of this proposed rule, consistent with section 1848(q)(1)(D)(i)(I) & (II) of the Act.

Under this option, we are proposing that performance on advancing care information performance category objectives and measures would be assessed and reported at the group level, as opposed to the individual MIPS eligible clinician level. We note that the data submission criteria would be the same when submitted at the group-level as if submitted at the individual-level, but the data submitted would be aggregated for all MIPS eligible clinicians within the group practice. We believe this approach to data submission better reflects the team dynamics of groups, and would reduce the overall reporting burden for MIPS eligible clinicians that practice in groups, incentivize practice-wide approaches to data submission, and provide enterprise-level continuous improvements strategies for submitting data to the advancing care information performance category. Please see section II.E.1.e. of this proposed rule for more discussion of how to participate as a group under MIPS.

(6) Reporting Requirements & Scoring Methodology

(a) Scoring Method

Section 1848(q)(5)(E)(i)(IV) of the Act, as added by section 101(c) of the MACRA, states that 25 percent of the MIPS CPS shall be based on performance for the advancing care information performance category. Therefore, we propose at § 414.1375 that performance in the advancing care information performance category will comprise 25 percent of a MIPS eligible clinician's CPS for payment year 2019 and each year thereafter. We received many comments in the MIPS and APMs RFI from stakeholders regarding the importance of flexible scoring for the advancing care information performance category and provisions for multiple performance pathways. We agree that this is the best approach moving forward with the adoption and use of certified EHR technology as it becomes part of a single coordinated program under the MIPS. For the reasons described here and previously in this preamble, we are proposing a methodology which balances the goals of incentivizing participation and reporting while recognizing exceptional performance by awarding points through a performance score. In this methodology, we are proposing at § 414.1380(b)(4) that the score for the advancing care information performance category would be comprised of a score for participation and reporting, hereinafter referred to as the “base score,” and a score for performance at varying levels above the base score requirements, hereinafter referred to as the “performance score”.

(b) Base Score

To earn points toward the base score, a MIPS eligible clinician must report the numerator and denominator of certain measures specified for the advancing care information performance category (see measure specifications in section II.E.5.g.7 of this proposed rule), which are based on the measures adopted by the EHR Incentive Programs for Stage 3 in the 2015 EHR Incentive Programs Final Rule, to account for 50 percent (out of a total 100 percent) of the advancing care information performance category score. For measures that include a percentage-based threshold for Stage 3 of the EHR Incentive Program, we would not require those thresholds to be met for purposes of the advancing care information performance category under MIPS, but would instead require MIPS eligible clinicians to report the numerator (of at least one) and denominator (or a yes/no statement for applicable measures, which would be submitted together with data for the other measures) for each measure being reported. We note that for any measure requiring a yes/no statement, only a yes statement would qualify for credit under the base score. Under the proposal, the base score of the advancing care information performance category would incorporate the objective and measures adopted by the EHR Incentive Programs with an emphasis on privacy and security. We are proposing two variations of a scoring methodology for the base score, a primary and an alternate proposal, which are outlined below. Both proposals would require the MIPS eligible clinician to meet the requirement to protect patient health information created or maintained by certified EHR technology to earn any score within the advancing care information performance category; failure to do so would result in a base score of zero, a performance score of zero (discussed in section II.E.5.g of this proposed rule), and an advancing care information performance category score of zero.

The primary proposal at section II.E.5.g.6.b.ii. of this proposed rule would require a MIPS eligible clinician to report the numerator (of at least one) and denominator or yes/no statement (only a yes statement would qualify for credit under the base score) for a subset of measures adopted by the EHR Incentive Program for EPs in the 2015 EHR Incentive Programs Final Rule. In an effort to streamline and simplify the reporting requirements under the MIPS, and reduce reporting burden on MIPS eligible clinicians, two objectives (Clinical Decision Support and Computerized Provider Order Entry) and their associated measures would not be required for reporting the advancing care information performance category. Given the consistently high performance on these two objectives in the EHR Incentive Program with EPs accomplishing a median score of over 90 percent for the last 3 years, we believe these objectives and measures are no longer an effective measure of EHR performance and use. In addition, we do not believe these objectives and associated measures contribute to the goals of patient engagement and interoperability, and thus believe these objectives can be removed in an effort to reduce reporting burden without negatively impacting the goals of the advancing care information performance category. We note that the removed objectives and associated measures would still be required as part of ONC's functionality standards for certified EHR technology, however, MIPS eligible clinicians would not be required to report the numerator and denominator or yes/no statement for those measures. In the 2015 EHR Incentive Programs Final Rule we also established that, for measures that were removed, the technology requirements would still be a part of the definition of certified EHR Start Printed Page 28221technology. For example, in that final rule, the Stage 1 Objective to Record Demographics was removed, but the technology and standard for this function in the EHR were still required (80 FR 62784). This means that the MIPS eligible clinician would still be required to have these functions as a part of their certified EHR technology.

The alternate proposal at section II.E.5.g.6.b.iii. of this proposed rule would require a MIPS eligible clinician to report the numerator (of at least one) and denominator or yes/no statement (only a yes statement would qualify for credit under the base score) for all objectives and measures adopted for Stage 3 in the 2015 EHR Incentive Programs Final Rule to earn the base score portion of the advancing care information performance category, which would include reporting a yes/no statement for Clinical Decision Support and a numerator and denominator for Computerized Provider Order Entry objectives. We include these objectives in the alternate proposal as MIPS eligible clinicians may feel the continued measurement of these objectives is valuable to the continued use of EHR technology as this would maintain the previously established objectives under the EHR Incentive Program.

We believe both proposed approaches to the base score are consistent with the statutory requirements and previously established certified EHR technology requirements as we transition to MIPS. We also believe both approaches, in conjunction with the advancing care information performance score, recognize the need for greater flexibility in scoring CEHRT use across different clinician types and practice settings by allowing MIPS eligible clinicians to focus on the objectives and measures most applicable to their practice.

(i) Privacy and Security; Protect Patient Health Information

In the 2015 EHR Incentive Programs Final Rule (80 FR 62832), we finalized the Protect Patient Health Information objective and its associated measure for Stage 3, which requires EPs to protect electronic protected health information (ePHI) created or maintained by the certified EHR technology through the implementation of appropriate technical, administrative, and physical safeguards. As privacy and security is of paramount importance and applicable across all objectives, the Protect Patient Health Information objective and measure would be an overarching requirement for the base score under both the primary proposal and alternate proposal, and therefore would be an overarching requirement for the advancing care information performance category. We propose that a MIPS eligible clinician must meet this objective and measure in order to earn any score within the advancing care information performance category. Failure to do so would result in a base score of zero under either the primary proposal or alternate proposal outlined below, as well as a performance score of zero (discussed in section II.E.5.g. of this proposed rule) and an advancing care information performance category score of zero.

In the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871), we finalized certain objectives and measures EPs would report to demonstrate meaningful use of certified EHR technology for Stage 3. Under our proposal for the base score of the advancing care information performance category, MIPS eligible clinicians would be required to submit the numerator (of at least one) and denominator, or yes/no statement as appropriate (only a yes statement would qualify for credit under the base score), for each measure within a subset of objectives (Electronic Prescribing, Patient Electronic Access to Health Information, Care of Coordination Through Patient Engagement, Health Information Exchange, and Public Health and Clinical Data Registry Reporting) adopted in the 2015 EHR Incentive Programs Final Rule for Stage 3 as outlined in Table 6 to account for the base score of 50 percent of the advancing care information performance category score. Successfully submitting a numerator and denominator or yes/no statement for each measure of each objective would earn a base score of 50 percent for the advancing care information performance category. Failure to meet the submission criteria (numerator/denominator or yes/no statement as applicable) and measure specifications (as defined in section II.E.5.g.7. of this proposed rule) for any measure in any of the objectives would result in a score of zero for the advancing care information performance category base score, a performance score of zero (discussed in section II.E.5.g. of this proposed rule) and an advancing care information performance category score of zero.

For the Public Health and Clinical Data Registry Reporting objective there is no numerator and denominator to measure; rather, the measure is a “yes/no” statement of whether the MIPS eligible clinician has completed the measure, noting that only a yes statement would qualify for credit under the base score. Therefore we are proposing that MIPS eligible clinicians would include a yes/no statement in lieu of the numerator/denominator statement within their submission for the advancing care information performance category for the Public Health and Clinical Data Registry Reporting objective. We further propose that, to earn points in the base score, a MIPS eligible clinician would only need to complete submission on the Immunization Registry Reporting measure of this objective. Completing any additional measures under this objective would earn one additional bonus point in the advancing care information performance category score. For further information on this proposed objective, we direct readers to section II.E.5.g.7. of this proposed rule.

Under our alternate proposal for the base score of the advancing care information performance category, a MIPS eligible clinician would be required to submit the numerator (of at least one) and denominator, or yes/no statement as appropriate, for each measure, for all objectives and measures for Stage 3 in the 2015 EHR Incentives Program Final Rule (80 FR 62829-62871) as outlined in Table 7. Successfully submitting a numerator and denominator for each measure of each objective would earn a base score of 50 percent for the advancing care information performance category. Failure to meet the submission requirements, or measure specifications for any measure in any of the objectives would result in a score of zero for the advancing care information performance category base score, a performance score of zero (discussed in Section II.E.5.g.), and an advancing care information performance category score of zero.

We propose the same approach in the alternate proposal for the Public Health and Clinical Data Registry Reporting objective as for the primary proposal outlined above. We direct readers to section II.E.5.g.7. for further details on the individual objectives and measures.

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(iv) Modified Stage 2 in 2017

In the 2015 EHR Incentive Programs final rule (80 FR 62772), we streamlined reporting for EPs by adopting a single set of objectives and measures for EPs regardless of their prior stage of participation. This was the first step in synchronizing the objectives and eliminating the separate stages of meaningful use in the EHR Incentive Program. In doing so, we also sought to provide some flexibility and to allow adequate time for EPs to move toward the more advanced use of EHR technology. This flexibility included alternate exclusions and specifications for EPs scheduled to demonstrate Stage 1 in 2015 and 2016 (80 FR 62788) and allowed clinicians to select either the Modified Stage 2 Objectives or the Stage 3 Objectives in 2017 (80 FR 62772) with all EPs moving to the Stage 3 Objectives in 2018. We note that in section II.E.5.g. of this proposed rule, we proposed the requirements for MIPS eligible clinicians using various editions of certified EHR technology in 2017 as it relates to the objectives and measures they select to report.

In connection with that proposal, and in an effort not to unfairly burden MIPS eligible clinicians who are still utilizing EHR technology certified to the 2014 Edition certification criteria in 2017, we propose at § 414.1380(b)(4) modified primary and alternate proposals for the base score for those MIPS eligible clinicians utilizing EHR technology certified to the 2014 Edition. We note that these modified proposals are the same as the primary and alternate proposals outlined above in regard to scoring and data submission, but vary in the measures required under the Coordination of Care Through Patient Engagement and Health Information Exchange objectives as demonstrated in Table 8.

This approach allows MIPS eligible clinicians to continue moving toward advanced use of certified EHR technology in 2018, but allows for flexibility in the implementation of upgraded technology and in the selection of measures for reporting in 2017.

We invite comments on our proposal.

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(c) Performance Score

In addition to the base score, which includes submitting each of the objectives and measures in order to achieve 50 percent of the possible points within the advancing care information performance category, we propose to allow multiple paths to achieve a score greater than the 50 percentage base score. The performance score is based on the priority goals established by CMS to focus on leveraging certified EHR technology to support the coordination of care. A MIPS eligible clinician would earn additional points above the base score for performance in the objectives and measures for Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange. These measures have a focus on patient engagement, electronic access and information exchange, which promote healthy behaviors by patients and lay the ground work for interoperability. These measures also have significant opportunity for improvement among eligible clinicians and the industry as a whole based on adoption and performance data. We believe this approach for achievement above a base score in the advancing care information performance category would provide MIPS eligible clinicians a flexible and realistic incentive towards the adoption and use of certified EHR technology.

We are proposing at § 414.1380(b)(4) that, for the performance score, the eight associated measures under these three objectives would each be assigned a total of 10 possible points. For each measure, a MIPS eligible clinician may earn up to 10 percent of their performance score based on their performance rate for the given measure. For example, a performance rate of 95 percent on a given measure would earn 9.5 percentage points of the performance score for the advancing care information performance category. This scoring approach is consistent with the performance score approach outlined for other MIPS categories in this proposed rule. Table 9 provides an example of the proposed performance score methodology.

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We note that in this methodology, a MIPS eligible clinician has the potential to earn a performance score of up to 80 percent, which, in combination with the base score would be greater than the total possible 100 percent for the advancing care information performance category. This methodology allows flexibility for MIPS eligible clinicians to focus on measures which are most relevant to their practice to achieve the maximum performance category score, while deemphasizing concentration in other measures which are not relevant to their practice.

This proposed methodology recognizes the importance of promoting health IT adoption and standards and the use of certified EHR technology to support quality improvement, interoperability, and patient engagement. We invite comments on our proposal.

(d) Overall Advancing Care Information Performance Category Score

To determine the MIPS eligible clinician's overall advancing care information performance category score, we propose to use the sum of the base score, performance score, and the potential Public Health and Clinical Data Registry Reporting bonus point. We note that if the sum of the MIPS eligible profession's base score (50 percent) and performance score (out of a possible 80 percent) with the Public Health and Clinical Data Registry Reporting bonus point are greater than 100 percent, we would apply an advancing care information performance category score of 100 percent. For example, if the MIPS eligible clinician earned the base score of 50 percent, a performance score of 60 percent and the bonus point for Public Health and Clinical Data Registry Reporting for a total of 111 percent, the MIPS eligible clinician's overall advancing care information performance category score would be 100 percent. The total percentage score (out of 100) for the advancing care information performance category would then be applied to the 25 points allocated for the advancing care information performance category and incorporated into the MIPS CPS, as described in section II.E.6. of this proposed rule. Table 10 provides an example of the calculation of the advancing care information performance category score based on these proposals.

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(e) Scoring Considerations

Section 1848(q)(5)(E)(ii) of the Act, as added by section 101(c) of the MACRA, provides that in any year in which the Secretary estimates that the proportion of EPs (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the MIPS CPS, but not below 15 percent, and increase the weightings of the other performance categories such that the total percentage points of the increase equals the total percentage points of the reduction. We note section 1848(o)(5) of the Act defines an EP as a physician, as defined in section 1861(r) of the Act. For purposes of applying section 1848(q)(5)(E)(ii) of the Act, we propose to estimate the proportion of physicians as defined in section 1861(r) who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of at least 75 percent under our proposed scoring methodology for the advancing care information performance category for a performance period. This would require the MIPS eligible clinician to earn the advancing care information base score of 50 percent, and an advancing care information performance score of at least 25 percent (or 24 percent plus the Public Health and Clinical Data Registry Reporting bonus point) for an overall performance category score of 75 percent for the advancing care information performance category. We are alternatively proposing to estimate the proportion of physicians as defined in section 1861(r) who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of 50 percent (which would only require the MIPS eligible clinician to earn the advancing care information base score) under our proposed scoring methodology for the advancing care information performance category for a performance period, and we seek comments on both of these proposed thresholds.

We propose to base this estimation on data from the relevant performance period, if we have sufficient data available from that period. For example, if feasible, we would consider whether to reduce the applicable percentage weight of the advancing care information performance category in the MIPS CPS for the 2019 MIPS payment year based on an estimation using the data from the 2017 performance period. We note that in section II.E.5.g.8. of this proposed rule, we have proposed to reweight the advancing care information performance category to zero for certain hospital-based physicians and other physicians. These physicians meet the definition of MIPS eligible clinicians, but would not be included in the estimation because the advancing care information performance category would be weighted at zero for them. We note that any adjustments of the performance category weights specified in section 1848(q)(5)(E) of the Act based on this policy would be established in future notice and comment rulemaking.

(a) MIPS Objectives and Measures Specifications

We propose the objectives and measures for the advancing care information performance category of MIPS as outlined in this section of the proposed rule. We note that these objectives and measures have been adapted from the Stage 3 objectives and measures as finalized in the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871), however, we have not proposed to maintain the previously established thresholds for MIPS. Any additional changes to the objectives and measures are outlined in this section of the proposed rule. For a more detailed discussion of the Stage 3 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871).

Objective: Protect Patient Health Information

Objective: Protect electronic protected health information (ePHI) created or maintained by the certified EHR technology through the implementation of appropriate technical, administrative, and physical safeguards

Security Risk Analysis Measure: Conduct or review a security risk analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including addressing the security (to include encryption) of ePHI data created or maintained by certified EHR technology in accordance with requirements in 45 CFR164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the MIPS eligible clinician's risk management process.

ePrescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using certified EHR technology.Start Printed Page 28227

Denominator: Number of prescriptions written for drugs requiring a prescription in order to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription in order to be dispensed during the performance period.

Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using certified EHR technology.

For this objective, we note that the 2015 EHR Incentive Program final rule included a discussion of controlled substances in the context of the Stage 3 objective and measure (80 FR 62834), which we understand from stakeholders has caused confusion. We are therefore proposing for both MIPS and for the EHR Incentive Programs that health care providers would continue to have the option to include or not include controlled substances that can be electronically prescribed in the denominator. This means that health care providers may choose to include controlled substances in the definition of “permissible prescriptions” at their discretion where feasible and allowable by law in the jurisdiction where they provide care. The health care provider may also choose not to include controlled substances in the definition of “permissible prescriptions” even if such electronic prescriptions are feasible and allowable by law in the jurisdiction where they provide care.

Clinical Decision Support (CDS) Interventions Measure: Implement three clinical decision support interventions related to three CQMs at a relevant point in patient care for the entire performance period. Absent three CQMs related to a MIPS eligible clinician's scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions.

Drug Interaction and Drug-Allergy Checks Measure: The MIPS eligible clinician has enabled and implemented the functionality for drug-drug and drug-allergy interaction checks for the entire performance period.

Objective: Use computerized provider order entry (CPOE) for medication, laboratory, and diagnostic imaging orders directly entered by any licensed healthcare professional, credentialed medical assistant, or a medical staff member credentialed to and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines.

Medication Orders Measure: At least one medication order created by the MIPS eligible clinician during the performance period is recorded using CPOE.

Denominator: Number of medication orders created by the MIPS eligible clinician during the performance period.

Numerator: The number of orders in the denominator recorded using CPOE.

Laboratory Orders Measure: At least one laboratory order created by the MIPS eligible clinician during the performance period is recorded using CPOE.

Denominator: Number of laboratory orders created by the MIPS eligible clinician during the performance period.

Numerator: The number of orders in the denominator recorded using CPOE.

Diagnostic Imaging Orders Measure: At least one diagnostic imaging order created by the MIPS eligible clinician during the performance period is recorded using CPOE.

Denominator: Number of diagnostic imaging orders created by the MIPS eligible clinician during the performance period.

Numerator: The number of orders in the denominator recorded using CPOE.

Patient Access Measure: For at least one unique patient seen by the MIPS eligible clinician: (1) The patient (or the patient authorized representative) is provided timely access to view online, download, and transmit his or her health information; and (2) The MIPS eligible clinician ensures the patient's health information is available for the patient (or patient—authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the Application Programing Interface (API) in the MIPS eligible clinician's certified EHR technology.

Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator (or patient authorized representative) who are provided timely access to health information to view online, download, and transmit to a third party and to access using an application of their choice that is configured meet the technical specifications of the API in the MIPS eligible clinician's certified EHR technology.

Patient-Specific Education Measure: The MIPS eligible clinician must use clinically relevant information from certified EHR technology to identify patient-specific educational resources and provide electronic access to those materials to at least one unique patient seen by the MIPS eligible clinician.

Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator who were provided electronic access to patient-specific educational resources using clinically relevant information identified from certified EHR technology during the performance period.

Objective: Coordination of Care Through Patient Engagement.

Objective: Use certified EHR technology to engage with patients or their authorized representatives about the patient's care.

View, Download, Transmit (VDT) Measure: During the performance period, at least one unique patient (or patient-authorized representatives) seen by the MIPS eligible clinician actively engages with the EHR made accessible by the MIPS eligible clinician. An MIPS eligible clinician may meet the measure by either—(1) view, download or transmit to a third party their health information; or (2) access their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the MIPS eligible clinician's certified EHR technology; or (3) a combination of (1) and (2).

Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information during the performance period and the number of unique patients (or their authorized representatives) in the denominator who have accessed their health information through the use of an API during the performance period.

Secure Messaging Measure: For at least one unique patient seen by the MIPS eligible clinician during the Start Printed Page 28228performance period, a secure message was sent using the electronic messaging function of certified EHR technology to the patient (or the patient-authorized representative), or in response to a secure message sent by the patient (or the patient-authorized representative).

Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator for whom a secure electronic message is sent to the patient (or patient-authorized representative) or in response to a secure message sent by the patient (or patient-authorized representative), during the performance period.

Patient-Generated Health Data Measure: Patient-generated health data or data from a non-clinical setting is incorporated into the certified EHR technology for at least one unique patient seen by the MIPS eligible clinician during the performance period.

Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator for whom data from non-clinical settings, which may include patient-generated health data, is captured through the certified EHR technology into the patient record during the performance period.

Objective: Health Information Exchange.

Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care providers into their EHR using the functions of certified EHR technology.

Patient Care Record Exchange Measure: For at least one transition of care or referral, the MIPS eligible clinician that transitions or refers their patient to another setting of care or health care provider—(1) creates a summary of care record using certified EHR technology; and (2) electronically exchanges the summary of care record.

Denominator: Number of transitions of care and referrals during the performance period for which the MIPS eligible clinician was the transferring or referring clinician.

Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using certified EHR technology and exchanged electronically.

Request/Accept Patient Care Record Measure: For at least one transition of care or referral received or patient encounter in which the MIPS eligible clinician has never before encountered the patient, the MIPS eligible clinician receives or retrieves and incorporates into the patient's record an electronic summary of care document.

Denominator: Number of patient encounters during the performance period for which a MIPS eligible clinician was the receiving party of a transition or referral or has never before encountered the patient and for which an electronic summary of care record is available.

Numerator: Number of patient encounters in the denominator where an electronic summary of care record received is incorporated by the clinician into the certified EHR technology.

Clinical Information Reconciliation Measure: For at least one transition of care or referral received or patient encounter in which the MIPS eligible clinician has never before encountered the patient, the MIPS eligible clinician performs clinical information reconciliation. The clinician must implement clinical information reconciliation for the following three clinical information sets: (1) Medication. Review of the patient's medication, including the name, dosage, frequency, and route of each medication. (2) Medication allergy. Review of the patient's known medication allergies. (3) Current Problem list. Review of the patient's current and active diagnoses.

Denominator: Number of transitions of care or referrals during the performance period for which the MIPS eligible clinician was the recipient of the transition or referral or has never before encountered the patient.

Numerator: The number of transitions of care or referrals in the denominator where the following three clinical information reconciliations were performed: Medication list, medication allergy list, and current problem list.

Objective: Public Health and Clinical Data Registry Reporting

Objective: The MIPS eligible clinician is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using certified EHR technology, except where prohibited, and in accordance with applicable law and practice.

Immunization Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit immunization data and receive immunization forecasts and histories from the public health immunization registry/immunization information system (IIS).

(Optional) Syndromic Surveillance Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit syndromic surveillance data from a non-urgent care ambulatory setting where the jurisdiction accepts syndromic data from such settings and the standards are clearly defined.

(Optional) Electronic Case Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to electronically submit case reporting of reportable conditions.

(Optional) Public Health Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit data to public health registries.

We propose the Modified Stage 2 objectives and measures for the advancing care information performance category of MIPS as outlined in this section of the proposed rule. We note that these objectives and measures have been adapted from the Modified Stage 2 objectives and measures as finalized in the 2015 EHR Incentive Programs Final Rule (80 FR 62793—62825), however, we have not proposed to maintain the previously established thresholds for MIPS. Any additional changes to the objectives and measures are outlined in this section of the proposed rule. For a more detailed discussion of the Modified Stage 2 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs Final Rule (80 FR 62793—62825).

Objective: Protect Patient Health Information

Objective: Protect electronic protected health information (ePHI) created or maintained by the certified EHR technology through the implementation of appropriate technical, administrative, and physical safeguards.

Security Risk Analysis Measure: Conduct or review a security risk analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including addressing the security (to include encryption) of ePHI data created Start Printed Page 28229or maintained by certified EHR technology in accordance with requirements in 45 CFR164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the MIPS eligible clinician's risk management process.

ePrescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using certified EHR technology.

Denominator: Number of prescriptions written for drugs requiring a prescription in order to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription in order to be dispensed during the performance period.

Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using certified EHR technology.

Clinical Decision Support (CDS) Interventions Measure: Implement three clinical decision support interventions related to three CQMs at a relevant point in patient care for the entire performance period. Absent three CQMs related to a MIPS eligible clinician's scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions.

Drug Interaction and Drug-Allergy Checks Measure: The MIPS eligible clinician has enabled and implemented the functionality for drug-drug and drug-allergy interaction checks for the entire performance period.

Objective: Computerized Provider Order Entry

Objective: Use computerized provider order entry (CPOE) for medication, laboratory, and diagnostic imaging orders directly entered by any licensed healthcare professional, credentialed medical assistant, or a medical staff member credentialed to and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines.

Medication Orders Measure: At least one medication order created by the MIPS eligible clinician during the performance period is recorded using CPOE.

Denominator: Number of medication orders created by the MIPS eligible clinician during the performance period.

Numerator: The number of orders in the denominator recorded using CPOE.

Laboratory Orders Measure: At least one laboratory order created by the MIPS eligible clinician during the performance period is recorded using CPOE.

Denominator: Number of laboratory orders created by the MIPS eligible clinician during the performance period.

Numerator: The number of orders in the denominator recorded using CPOE.

Diagnostic Imaging Orders Measure: At least one diagnostic imaging order created by the MIPS eligible clinician during the performance period is recorded using CPOE.

Denominator: Number of diagnostic imaging orders created by the MIPS eligible clinician during the performance period.

Numerator: The number of orders in the denominator recorded using CPOE.

Patient Access Measure: At least one patient seen by the MIPS eligible clinician during the performance period is provided timely access to view online, download, and transmit to a third party their health information subject to the MIPS eligible clinician's discretion to withhold certain information.

Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator (or patient authorized representative) who are provided timely access to health information to view online, download, and transmit to a third party.

View, Download, Transmit (VDT) Measure: At least one patient seen by the MIPS eligible clinician during the performance period (or patient-authorized representative) views, downloads or transmits their health information to a third party during the performance period.

Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information during the performance period.

Patient-Specific Education Measure: The MIPS eligible clinician must use clinically relevant information from certified EHR technology to identify patient-specific educational resources and provide access to those materials to at least one unique patient seen by the MIPS eligible clinician.

Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator who were provided access to patient-specific educational resources using clinically relevant information identified from certified EHR technology during the performance period.

Objective: Secure Messaging

Objective: Use certified EHR technology to engage with patients or their authorized representatives about the patient's care.

Secure Messaging Measure: For at least one patient seen by the MIPS eligible clinician during the performance period, a secure message was sent using the electronic messaging function of certified EHR technology to the patient (or the patient-authorized representative), or in response to a secure message sent by the patient (or the patient authorized representative) during the performance period.

Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.

Numerator: The number of patients in the denominator for whom a secure electronic message is sent to the patient (or patient-authorized representative) or in response to a secure message sent by the patient (or patient-authorized representative), during the performance period.

Objective: Health Information Exchange

Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care Start Printed Page 28230information from other health care providers into their EHR using the functions of certified EHR technology.

Health Information Exchange Measure: The MIPS eligible clinician that transitions or refers their patient to another setting of care or health care provider (1) uses certified EHR technology to create a summary of care record; and (2) electronically transmits such summary to a receiving health care provider for at least one transition of care or referral.

Denominator: Number of transitions of care and referrals during the performance period for which the EP was the transferring or referring health care provider.

Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using certified EHR technology and exchanged electronically.

Objective: Medication Reconciliation

Medication Reconciliation Measure: The MIPS eligible clinician performs medication reconciliation for at least one transition of care in which the patient is transitioned into the care of the MIPS eligible clinician.

Denominator: Number of transitions of care or referrals during the performance period for which the MIPS eligible clinician was the recipient of the transition or referral or has never before encountered the patient.

Numerator: The number of transitions of care or referrals in the denominator where the following three clinical information reconciliations were performed: Medication list, medication allergy list, and current problem list.

Objective: Public Health Reporting

Objective: The MIPS eligible clinician is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using certified EHR technology, except where prohibited, and in accordance with applicable law and practice.

Immunization Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit immunization data.

Syndromic Surveillance Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit syndromic surveillance data.

Specialized Registry Reporting Measure: The MIPS eligible clinician is in active engagement to submit data to a specialized registry.

We invite comments on our proposal.

(c) Exclusions

In the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871) we outlined certain exclusions from the objectives and measures of meaningful use for EPs who perform low numbers of a particular action or activity for a given measure (for example, an EP who writes fewer than 100 permissible prescriptions during the EHR reporting period would be granted an exclusion for the Electronic Prescribing measure) or for EPs who had no office visits during the EHR reporting period. Moving forward, we believe that the proposed MIPS exclusion criteria as outlined in section II.E.3. of this proposed rule, and advancing care information performance category scoring methodology together accomplish the same end as the previously established exclusions for the majority of the advancing care information measures. By excluding from MIPS those clinicians who do not exceed the low-volume threshold (proposed in section II.E.3.c. as MIPS eligible clinicians who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provide care for 100 or fewer Part B-enrolled Medicare beneficiaries), we believe exclusions for most of the individual advancing care information measures are no longer necessary. The additional flexibility afforded by the proposed advancing care information performance category scoring methodology eliminates required thresholds for measures and allows MIPS eligible clinicians to focus on, and therefore report higher numbers for, measures that are more relevant to their practice.

We note that EPs who write less than 100 permissible prescriptions during the EHR reporting period are allowed an exclusion for the Electronic Prescribing measure under the EHR Incentive Program (80 FR 62834), which we do not propose for MIPS. We note that the Electronic Prescribing objective would not be part of the performance score under our proposals, and thus MIPS eligible clinicians who write very low numbers of permissible prescriptions would not be at a disadvantage in relation to other MIPS eligible clinicians when seeking to achieve a maximum advancing care information performance category score. For the purposes of the base score, we are proposing that those MIPS eligible clinicians who write fewer than 100 permissible prescriptions in a performance period may elect to report their numerator and denominator (if they have at least one permissible prescription for the numerator), or they may report a null value. This is consistent with prior policy which allowed flexibility for clinicians in similar circumstances to choose an alternate exclusion (80 FR 62789).

In addition, in the 2015 EHR Incentive Programs final rule, we adopted a set of exclusions for the Immunization Registry Reporting measure under the Public Health and Clinical Data Registry Reporting objective (80 FR 62870). We recognize that some types of clinicians do not administer immunizations, and are therefore proposing to maintain the previously established exclusions for the Immunization Registry Reporting measure. We are therefore proposing that these MIPS eligible clinicians may elect to report their yes/no statement if applicable, or they may report a null value (if the previously established exclusions apply) for purposes of reporting the base score.

We note that we are not proposing to maintain any of the other exclusions established under the EHR Incentive Program, however, we are seeking comment on whether other exclusions should be considered under the advancing care information performance category under the MIPS.

(8) Additional Considerations

(a) Reweighting of the Advancing Care Information Performance Category for MIPS Eligible Clinicians Without Sufficient Measures Applicable and Available

As discussed previously in this proposed rule, section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment at the end of CY 2018. Section 1848(a)(7) of the Act includes certain statutory exceptions to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. Specifically, section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under section 1848(a)(7)(A) of the Act. In addition, section 1848(a)(7)(B) of the Act provides that the Secretary may exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The MACRA did not maintain these statutory Start Printed Page 28231exceptions for the advancing care information performance category of the MIPS. Thus, the exceptions under sections 1848(a)(7)(B) and (D) of the Act are limited to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act and do not apply in the context of the MIPS.

Section 1848(q)(5)(F) of the Act provides, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable to each type of MIPS eligible clinician, and for each measure and activity specified for each such category based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician.

We believe that under our proposals for the advancing care information performance category of the MIPS, there may not be sufficient measures that are applicable and available to certain types of MIPS eligible clinicians as outlined in this section of this proposed rule, some of whom may have qualified for a statutory exception to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. For the reasons stated below, we propose to assign a weight of zero to the advancing care information performance category for purposes of calculating a MIPS CPS for these MIPS eligible clinicians. We refer readers to section II.E.6. of this proposed rule for more information regarding how the quality, resource use and CPIA performance categories would be reweighted.

(i) Hospital-Based MIPS Eligible Clinicians

Section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. We defined a hospital-based EP for the EHR Incentive Program under § 495.4 as an EP who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an inpatient hospital or emergency room setting in the year preceding the payment year, or in the case of a payment adjustment year, in either of the 2 years before the year preceding such payment adjustment year. Under this definition, EPs that have 90 percent or more of payments for covered professional services associated with claims with Place of Service Codes 21 (inpatient hospital) or 23 (emergency department) are considered hospital-based (75 FR 44442).

We believe there may not be sufficient measures applicable and available to hospital-based MIPS eligible clinicians under our proposals for the advancing care information performance category of MIPS.

Hospital-based MIPS eligible clinicians may not have control over the decisions that the hospital makes regarding the use of health IT and certified EHR technology. These MIPS eligible clinicians therefore may have no control over the type of certified EHR technology available, the way that the technology is implemented and used, or whether the hospital continually invests in the technology to ensure it is compliant with ONC certification criteria. In addition, some of the specific advancing care information performance category measures, such as the Patient Access measure under the Patient Electronic Access objective requires that patients have access to view, download and transmit their health information from the EHR which is made available by the health care provider, in this case the hospital. Thus the measure is more attributable and applicable to the hospital and not to the MIPS eligible clinician, as the hospital controls the availability of the EHR technology. Further, the requirement under the Protect Patient Health Information objective to conduct a security risk analysis, would rely on the actions of the hospital, rather than the actions of the MIPS eligible clinician, as the hospital controls the access and availability and secure implementation of the EHR technology. In this case, the measure is again more attributable and applicable to the hospital than to the MIPS eligible clinician. Further, certain specialists (such as pathologists, radiologists and anesthesiologists) who often practice in a hospital setting and may be hospital-based MIPS eligible clinicians often lack face-to-face interaction with patients, and thus may not have sufficient measures applicable and available to them under our proposals. For example, hospital-based MIPS eligible clinicians who lack face-to-face patient interaction may not have patients for which they could transfer or create an electronic summary of care record.

In addition, we note that eligible hospitals and CAHs are subject to meaningful use requirements under sections 1886(b)(3)(B) and (n) and 1814(l) of the Act, respectively, which were not affected by the enactment of the MACRA. Eligible hospitals and CAHs are required to report on objectives and measures of meaningful use under the EHR Incentive Program, as outlined in the 2015 EHR Incentive Programs Final Rule. We note the objectives and measures of the EHR Incentive Programs for eligible hospitals and CAHs are specific to these facilities, and are more applicable and better represent the EHR technology available in these settings.

For these reasons, we propose to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category for hospital-based MIPS eligible clinicians. We propose to define a “hospital-based MIPS eligible clinician” at § 414.1305 as a MIPS eligible clinician who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an inpatient hospital or emergency room setting in the year preceding the performance period, otherwise stated as the year three years preceding the MIPS payment year. For example, under this proposal, hospital-based determinations would be made for the 2019 MIPS payment year based on covered professional services furnished in 2016. We also propose, consistent with the EHR Incentive Program, that CMS would determine which MIPS eligible clinicians qualify as “hospital-based” for a MIPS payment year. We invite comments on these proposals.

In addition, we are seeking comment on how the advancing care information performance category could be applied to hospital-based MIPS eligible clinicians in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.

We are also seeking comment on whether the previously established 90 percent threshold of payments for covered professional services associated with claims with Place of Service (POS) Codes 21 (inpatient hospital) or 23 (emergency department) is appropriate, or whether we should consider lowering this threshold to account for hospital-based MIPS eligible clinicians who bill more than 10 percent of claims with a POS other than 21 or 23. Although we have proposed a threshold of 90 percent, we are considering whether a lower threshold would be more appropriate for hospital-based MIPS eligible clinicians. In particular, we are interested in what factors should be applied to determine the threshold for hospital-based MIPS eligible clinicians. We will continue to evaluate the data to determine whether there are certain thresholds which naturally define a hospital-based MIPS eligible clinician.Start Printed Page 28232

(ii) MIPS Eligible Clinicians Facing a Significant Hardship

Section 1848(a)(7)(B) of the Act provides that the Secretary may exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship. In the Stage 2 Final Rule (77 FR 54097-54100), we defined certain categories of significant hardships that may prevent an EP from meeting the requirements of being a meaningful EHR user. These categories include:

We believe that under our proposals for the advancing care information performance category, there may not be sufficient measures applicable and available to MIPS eligible clinicians within the categories above. For these MIPS eligible clinicians, we propose to rely on section 1848(q)(5)(F) of the Act to re-weight the advancing care information performance category to zero.

Sufficient internet access is fundamental to many of the measures proposed for the advancing care information performance category. For example, the ePrescribing measure requires sufficient access to the Internet to transmit prescriptions electronically, and the Secure Messaging measure requires sufficient Internet access to receive and respond to patient messages. These measures may not be applicable to MIPS eligible clinicians who practice in areas with insufficient internet access. We propose to require MIPS eligible clinicians to demonstrate insufficient internet access through an application process in order to be considered for a reweighting of the advancing care information performance category. The application would have to demonstrate that the MIPS eligible clinicians lacked sufficient internet access, during the performance period, and that there were insurmountable barriers to obtaining such infrastructure, such as a high cost of extending the internet infrastructure to their facility.

Extreme and uncontrollable circumstances, such as a natural disaster in which an EHR or practice building are destroyed, can happen at any time and are outside a MIPS eligible clinician's control. If a MIPS eligible clinician's certified EHR technology is unavailable as a result of such circumstances, the measures specified for the advancing care information performance category may not be available for the MIPS eligible clinician to report. We propose that these MIPS eligible clinicians submit an application to include the circumstances by which the EHR technology was unavailable, and for what period of time it was unavailable, to be considered for reweighting of their advancing care information performance category.

In the Stage 2 Final Rule (77 FR 54100) we discussed EPs who practice at multiple locations, and may not have the ability to impact their practices' health IT decisions. We noted the case of surgeons using ambulatory surgery centers or a physician treating patients in a nursing home who does not have any other vested interest in the facility, and may have no influence or control over the health IT decisions of that facility. If MIPS eligible clinicians lack control over the EHR technology in their practice locations, then the measures specified for the advancing care information performance category may not be available to them for reporting. To be considered for a reweighting of the advancing care information performance category, we propose that these MIPS eligible clinicians would need to submit an application demonstrating that a majority (50 percent or more) of their outpatient encounters occur in locations where they have no control over the health IT decisions of the facility, and request their advancing care information performance category score be reweighted to zero. We note that in such cases, the MIPS eligible clinician must have no control over the availability of certified EHR technology. Control does not imply final decision-making authority. For example, we would generally view MIPS eligible clinicians practicing in a large group as having control over the availability of certified EHR technology, because they can influence the group's purchase of certified EHR technology, they may reassign their claims to the group, they may have a partnership/ownership stake in the group, or any payment adjustment would affect the group's earnings and the entire impact of the adjustment would not be borne by the individual MIPS eligible clinician. These MIPS eligible clinicians can influence the availability of certified EHR technology and the group's earnings are directly affected by the payment adjustment. Thus, such MIPS eligible clinicians would not, as a general rule, be viewed as lacking control over the availability of certified EHR technology and would not be eligible for their advancing care information performance category to be reweighted based on their membership in a group practice that has not adopted certified EHR technology.

In the Stage 2 Final Rule (77 FR 54099), we noted the challenges faced by EPs who lack face-to-face interaction with patients (EPs that are non-patient facing), or lack the need to provide follow-up care with patients. Many of the measures proposed under the advancing care information performance category require face-to-face interaction with patients, including all eight of the measures that make up the three performance score objectives (Patient Electronic Access, Coordination of Care Through Patient Engagement and Health Information Exchange). Because these proposed measures rely so heavily on face-to-face patient interactions, we do not believe there would be sufficient measures applicable to non-patient-facing MIPS eligible clinicians under the advancing care information performance category. We propose to automatically reweight the advancing care information performance category to zero for a MIPS eligible clinician who is classified as a non-patient facing MIPS eligible clinician (based on the number of patient-facing encounters billed during a performance period) without requiring an application to be submitted by the MIPS eligible clinician. We refer readers to section II.E.1.b. of this proposed rule for further discussion of non-patient facing MIPS eligible clinicians. We are seeking comment on how the advancing care information performance category could be applied to non-patient facing MIPS eligible clinicians in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.

We propose that all applications for reweighting the advancing care information performance category be submitted by the MIPS eligible clinician or designated group representative in the form and manner specified by CMS. We propose that all applications may be submitted on a rolling basis, but must be received by CMS no later than the close of the submission period for the relevant performance period, or a later date specified by CMS. For example, for the 2017 performance period, applications Start Printed Page 28233must be submitted no later than March 31, 2018 (or later date as specified by CMS) to be considered for reweighting the advancing care information performance category for the 2019 MIPS payment year. An application would need to be submitted annually to be considered for reweighting each year.

The definition of a MIPS EP under section 1848(q)(1)(C) of the Act includes certain non-physician practitioners, including Nurse Practitioners (NPs), Physicians Assistants (PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical Nurse Specialists (CNSs)). CRNAs and CNSs are not eligible for the incentive payments under Medicare or Medicaid for the adoption and meaningful use of certified EHR technology (sections 1848(o) and 1903(t) of the Act, respectively) or subject to the meaningful use payment adjustment under Medicare (section 1848(a)(7)(A) of the Act), and thus they may have little to no experience with the adoption or use of certified EHR technology. Similarly, NPs and PAs may also lack experience with the adoption or use of certified EHR technology, as they are not subject to the payment adjustment under section 1848(a)(7)(A) of the Act. We further note that only 19,281 NPs and only 1,379 PAs have attested to the Medicaid EHR Incentive Program. Nurse practitioners are eligible for the Medicaid incentive payments under section 1903(t) of the Act, as are PAs practicing in a Federally Qualified Health Center (FQHC) or a rural health clinic (RHC) that is led by a PA, if they meet patient volume requirements and other eligibility criteria.

Because many of these non-physician clinicians are not eligible to participate in the Medicare and/or Medicaid EHR Incentive Program, we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under our proposals for the advancing care information performance category. The low numbers of NPs and PAs who have attested for the Medicaid incentive payments may indicate that EHR Incentive Program measures required to earn the incentive are not applicable or available, and thus would not be applicable or available under the advancing care information performance category. For these reasons, we propose to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We would assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the advancing care information performance category. We encourage all NPs, PAs, CRNAs, and CNSs to report on these measures to the extent they are applicable and available, however, we understand that some NPs, PAs, CRNAs, and CNSs may choose to accept a weight of zero for this performance category if they are unable to fully report the advancing care information measures. We believe this approach is appropriate for the first MIPS performance period based on the payment consequences associated with reporting, the fact that many of these types of MIPS eligible clinicians may lack experience with EHR use, and our current uncertainty as to whether we have proposed sufficient measures that are applicable and available to these types of MIPS eligible clinicians. We note that we would use the first MIPS performance period to further evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category and would consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians.

We invite comments on our proposal. We are additionally seeking comment on how the advancing care information performance category could be applied to NPs, PAs, CRNAs, and CNSs in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.

(iv) Medicaid

In the 2015 EHR Incentive Programs Final Rule we adopted an alternate method for demonstrating meaningful use for certain Medicaid EPs that would be available beginning in 2016, for EPs attesting for an EHR reporting period in 2015 (80 FR 62900). Medicaid EPs who previously received an incentive payment under the Medicaid EHR Incentive Program, but failed to meet the eligibility requirements for the program in subsequent years, are permitted to attest using the CMS Registration and Attestation system for the purpose of avoiding the Medicare payment adjustment (80 FR 62900). However, as discussed previously in this proposed rule, section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment for Medicare EHR Incentive Program EPs at the end of CY 2018. This means that after the CY 2018 payment adjustment year, there will no longer be a separate Medicare EHR Incentive Program for EPs, and therefore Medicaid EPs who may have used this alternate method for demonstrating meaningful use cannot potentially be subject to a payment adjustment under the Medicare EHR Incentive Program at that time. Accordingly, there will no longer be a need for this alternate method of demonstrating meaningful use after the CY 2018 payment adjustment year.

Similarly, beginning in 2014, states were required to collect, upload and submit attestation data for Medicaid EPs for the purposes of demonstrating meaningful use to avoid the Medicare payment adjustment (80 FR 62915). This form of reporting will also no longer need to continue with the sunset of the meaningful use payment adjustment for Medicare EHR Incentive Program EPs at the end of CY 2018. Accordingly, we are proposing to amend the reporting requirement described at 42 CFR 495.316(g) by adding an ending date such that after the CY 2018 payment adjustment year states would no longer be required to report on meaningful EHR users.

We note that the Medicaid EHR Incentive Program for EPs was not impacted by the MACRA and the requirement under section 1848(q) of the Act to establish the MIPS program. In this rule, we do not propose any changes to the objectives and measures previously established in rulemaking for the Medicaid EHR Incentive Program, and thus EPs participating in that program must continue to report on the objectives and measures under the guidelines and regulations of that program.

Accordingly, reporting on the measures specified for the advancing care information performance category under MIPS cannot be used as a demonstration of meaningful use for the Medicaid EHR Incentive Programs. Similarly, a demonstration of meaningful use in the Medicaid EHR Incentive Programs cannot be used for purposes of reporting under MIPS.

Therefore, MIPS eligible clinicians who are also participating in the Medicaid EHR Incentive Programs must report their data for the advancing care information performance category through the submission methods established for MIPS in order to earn a score for the advancing care information performance category under MIPS and must separately demonstrate meaningful use in their state's Medicaid EHR Incentive Program in order to earn a Start Printed Page 28234Medicaid incentive payment. The Medicaid EHR Incentive Program continues through payment year 2021, with 2016 being the final year an EP can begin receiving incentive payments (§ 495.310(a)(1)(iii)). We solicit comments on alternative reporting or proxies for EPs who provide services to both Medicaid and Medicare patients and are eligible for both MIPS and the Medicaid EHR Incentive Payment.

Under section 1848(q)(1)(C)(ii) of the Act, as added by section 101(c)(1) of the MACRA and discussed above in section II.E.3.b. of this proposed rule, Qualifying APM Participants (QPs) are not MIPS eligible clinicians and are thus excluded from MIPS payment adjustments. Partial Qualifying APM Participants (Partial QPs) are also not MIPS eligible clinicians unless they opt to report and be scored under MIPS. All other eligible clinicians participating in APMs are MIPS eligible clinicians and subject to MIPS requirements, including reporting requirements and payment adjustments. However, most current APMs already assess their participants on cost and quality of care and require engagement in certain care improvement activities.

We propose at § 414.1370 to establish a scoring standard for MIPS eligible clinicians participating in certain types of APMs in order to reduce participant reporting burden by eliminating the need for such APM eligible clinicians to submit data for both MIPS and their respective APMs. For purposes of this APM scoring standard, we propose to consider a participant in an APM to be an entity participating in an APM under an agreement with CMS that may either include eligible clinicians or be an eligible clinician and that is directly tied to beneficiary attribution, quality measurement or cost/utilization measurement under the APM. In accordance with section 1848(q)(1)(D)(i) of the Act, we propose to assess the performance of a group of MIPS eligible clinicians in an APM Entity that participates in certain types of APMs based on their collective performance as an APM Entity group, as defined at § 414.1305.

In addition to reducing reporting burden, we seek to ensure that eligible clinicians in APM Entity groups are not assessed in multiple ways on the same performance activities. For instance, performance on the generally applicable resource use measures under MIPS could contribute to upward or downward adjustments to payments under MIPS in a way that is not aligned with the strategy in an ACO initiative for reducing total Medicare costs for a specified population of beneficiaries attributed through the unique ACO initiative's attribution methodology. Depending on the terms of the particular APM, we believe similar misalignments could be common between the MIPS quality and resource use performance categories and the evaluation of quality and resource use in APMs. We believe requiring eligible clinicians in APM Entity groups to submit data, be scored on measures, and be subject to payment adjustments that are not aligned between MIPS and an APM could potentially undermine the validity of testing or performance evaluation under the APM. We also believe imposition of these requirements would result in reporting activity that provides little or no added value to the assessment of eligible clinicians, and could confuse eligible clinicians as to which CMS incentives should take priority over others in designing and implementing care activities.

We are proposing to use the APM scoring standard for MIPS eligible clinicians in APM Entity groups participating in certain APMs that meet the criteria listed below (and are identified as “MIPS APMs” on the CMS Web site). In this section of the rule, we define the proposed criteria for MIPS APMs, the APM scoring standard, the performance period for APM Entity groups, the proposed MIPS scoring methodology for APM Entity groups, and other information related to the APM scoring standard.

(1) Criteria for MIPS APMs

We propose at § 414.1370 to specify that the APM scoring standard under MIPS would only be applicable to certain eligible clinicians participating in MIPS APMs, which we propose to define as APMs (as defined in section II.F.4. of this preamble) that meet the following criteria: (1) APM Entities participate in the APM under an agreement with CMS; (2) the APM Entities include one or more MIPS eligible clinicians on a Participation List; and (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures. We understand that under some APMs the APM Entity may enter into agreements with clinicians or entities that have supporting or ancillary roles to the APM Entity's performance under the APM, but are not participating under the APM Entity and therefore are not on a Participation List. We would not consider eligible clinicians under such arrangements to be participants for purposes of the APM Entity group to which the APM scoring standard would apply. We understand that this policy would not accommodate certain APMs pursuant to statute or our regulations rather than under an agreement with CMS. We seek comments on how the APM scoring standard should apply to those APMs as well.

The criteria for the identification of MIPS APMs are independent of the criteria for Advanced APM determinations discussed in section II.F.3. of this proposed rule, so a MIPS APM may or may not also be an Advanced APM. As such, it would be possible that an APM meets all three proposed criteria to be a MIPS APM, but does not meet the Advanced APM criteria listed in section II.F.4. Conversely, it would be possible, that an Advanced APM does not meet the criteria listed above because it does not include MIPS eligible clinicians as participants.

The APM scoring standard would not apply to MIPS eligible clinicians involved in APMs that include only facilities as participants (such as the Comprehensive Care for Joint Replacement Model). APMs that do not base payment on cost/utilization and quality measures (such as the Accountable Health Communities Model) would also not meet the proposed criteria for the APM scoring standard. Instead, MIPS eligible clinicians participating in these APMs would need to meet the generally applicable MIPS data submission requirements for the MIPS performance period, and their performance would be assessed using the generally applicable MIPS standards, either as individual eligible clinicians or as a group under MIPS.

As discussed above, the APM scoring standard described in this proposed rule would require MIPS eligible clinicians to report certain data under MIPS regardless of whether they ultimately become QPs or Partial QPs through their participation in Advanced APMs. Although QPs (and Partial QPs who elect not to participate in MIPS) would be excluded from MIPS payment adjustments, we believe it is necessary, for the operational and administrative reasons discussed in section II.F.5.d., to treat these eligible clinicians as MIPS eligible clinicians unless and until the QP or Partial QP determination is made. We believe the proposed APM scoring standard would help to alleviate certain duplicative, unnecessary, or competing data submission requirements for MIPS eligible clinicians participating in MIPS Start Printed Page 28235APMs. However, we are interested in public comments on alternative methods that could reduce MIPS data submission requirements to enable MIPS eligible clinicians participating in Advanced APMs to maximize their focus on the care delivery redesign necessary to succeed within the Advanced APM while maintaining the statutory framework that excludes only certain eligible clinicians from MIPS, and reducing reporting burden on Advanced APM participants.

We invite public comment on alternative MIPS data submission and scoring methods. Specifically, if, during a future performance period, we are able to make QP determinations before MIPS reporting must occur, we seek to attain the least amount of required MIPS data submission while avoiding unnecessary operational complexity.

(2) APM Scoring Standard Performance Period

We propose that the performance period for MIPS eligible clinicians participating in MIPS APMs would match the generally applicable performance period for MIPS proposed in section II.E.4 of this preamble. We propose this policy would apply to all MIPS eligible clinicians participating in MIPS APMs (those that meet the criteria specified in section II.E.5.h.1. of this proposed rule) except for a new MIPS APM for which the first APM performance period begins after the start of the corresponding MIPS performance period. In this instance, the participating MIPS eligible clinicians in the new MIPS APM would submit data to MIPS in the first MIPS performance period for the APM either as individual MIPS eligible clinicians or as a group using one of the MIPS data submission mechanisms for all four performance categories, and report to CMS using the APM scoring standard for subsequent MIPS performance period(s). Additionally, we anticipate that there might be MIPS APMs that would not be able to use the APM scoring standard (even though they met the criteria for the APM scoring standard and were treated as a MIPS APMs in the prior MIPS performance period) in their last year of operation because of technical or resource issues. For example, a MIPS APM in its final year may end earlier than the end of the MIPS performance period (proposed to be December 31). CMS might not have continuing resources dedicated or available to continue to support the MIPS APM activities under the APM scoring standard if the MIPS APM ends during the MIPS performance period. Therefore, if we determine it is not feasible for the MIPS eligible clinicians participating in the APM Entity to report to MIPS using this APM scoring standard in an APM's last year of operation, the MIPS eligible clinicians in the MIPS APM would need to submit data to MIPS either as individual MIPS eligible clinicians or as a group using one of the MIPS data submission mechanisms for the applicable performance period. We propose the eligible clinicians in the MIPS APM would be made aware of this decision in advance of the relevant MIPS performance period.

(3) How the APM Scoring Standard Differs From the Assessment of Groups and Individual MIPS Eligible Clinicians Under MIPS

We believe that establishing an APM scoring standard under MIPS would allow APM Entities and their participating eligible clinicians to focus on the goals and objectives of the APM to improve quality and lower costs of care while avoiding duplicative reporting that would occur as a result of having to submit data to MIPS separately. The APM scoring standard we propose is similar to group assessment under MIPS as described in section II.E.3.d. of this proposed rule, but would differ in one or more of the following ways: (1) Depending on the terms and conditions of the MIPS APM, an APM Entity could be comprised of a sole MIPS eligible clinician (for example, a physician practice with only one eligible clinician could be considered an APM Entity); (2) the APM Entity could include more than one unique TIN, as long as the MIPS eligible clinicians are identified as participants in the APM by their unique APM participant identifiers; (3) the composition of the APM Entity group could include APM participant identifiers with TIN/NPI combinations such that some MIPS eligible clinicians in a TIN are APM participants and other MIPS eligible clinicians in that same TIN are not APM participants. In contrast, assessment as a group under MIPS requires a group to be comprised of at least two MIPS eligible clinicians who have assigned their billing rights to a TIN. It also requires that all MIPS eligible clinicians in the group to use the same TIN.

In addition to the APM Entity group composition being potentially different than that of a group as generally defined under MIPS, we propose for the APM scoring standard that we will generate a MIPS CPS by aggregating all scores for MIPS eligible clinicians in the APM Entity that is participating in the MIPS APM to the level of the APM Entity. We believe that aggregating the MIPS performance category scores at the level of the APM Entity is more meaningful to, and appropriate for, these MIPS eligible clinicians because they have elected to participate in an APM and collectively focus on care transformation activities to improve the quality of care.

Further, we propose below that, depending on the type of MIPS APM, the weights associated with performance categories may be different than the generally applicable weights for MIPS eligible clinicians. The weights assigned to the MIPS performance categories under the APM scoring standard for MIPS eligible clinicians who are participating in a MIPS APM may be different from the performance category weights for MIPs eligible clinicians not participating in a MIPS APM for the same performance period. For example, we propose below that under the APM scoring standard, the weight for the resource use performance category will be zero. We also propose that for certain MIPS APMs, the weight for the quality performance category will be zero for the 2019 payment year. Where the weight for the performance category is zero, neither the APM Entity nor the MIPS eligible clinicians in the MIPS APM would need to report data in these categories, and we would redistribute the weights for the quality and resource use performance categories to the CPIA and advancing care information performance categories to maintain a CPS of 100 percent.

In order to implement certain elements of the APM scoring standard, we would need to use the Shared Savings Program (section 1899 of the Act) and CMS Innovation Center (section 1115A of the Act) authorities to waive specific statutory provisions related to MIPS reporting and scoring. Section 1899(f) of the Act authorizes waivers of title XVIII requirements as may be necessary to carry out the Shared Savings Program, and section 1115A(d)(1) of Act authorizes waivers of title XVIII requirements as may be necessary solely for purposes of testing models under section 1115A of the Act. In each section below in which we propose scoring methodologies and waivers to enable the proposed approaches, we describe how the use of waivers is necessary under the respective waiver authority standards. The underlying purpose of APMs is for CMS to pay for care in ways that are unique from fee-for-service payment and to test new ways of measuring and assessing performance. If the data submission requirements and associated adjustments under MIPS are not aligned Start Printed Page 28236with APM-specific goals and incentives, the participants receive conflicting messages from CMS on priorities, which could create uncertainty and severely degrade our ability to evaluate the impact of any particular APM on the overall cost and quality of care. Therefore, we believe that, for reasons stated in this section, certain waivers are necessary for testing and operating APMs and for maintaining the integrity of our evaluation of those APMs.

We note that for at least the first performance year, we do not anticipate that any APMs not authorized under sections 1115A or 1899 of the Act would meet the criteria to be MIPS APMs. In the event that we do anticipate other Federal demonstrations will become MIPS APMs, we will address MIPS scoring for participating eligible clinicians in future rulemaking.

(4) APM Participant Identifier and Participant Database

To ensure we have accurately captured performance data for all of the MIPS eligible clinicians that are participating in an APM, we would establish and maintain an APM participant database that will include all of the MIPS eligible clinicians who are part of the APM Entity. We would establish this database to track participation in all APMs, in addition to specifically tracking participation in MIPS APMs and Advanced APMs. We propose that each APM Entity be identified in the MIPS program by a unique APM Entity identifier. We also propose in section II.E.2.b. that the unique APM participant identifier for a MIPS eligible clinician would be a combination of four identifiers including: (1) APM identifier (established for the APM by CMS; for example, XXXXXX); (2) APM Entity identifier (established for the APM by CMS; for example, AA00001111); (3) the eligible clinician's billing TIN (for example, XXXXXXXXX); and (4) NPI (for example, 1111111111). For example, this APM participant identifier for the MIPS eligible clinician in this case would be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111. The use of the APM participant identifier will allow CMS to identify all MIPS eligible clinicians participating in an APM Entity, including instances when the MIPS eligible clinicians use a billing TIN that is shared with MIPS eligible clinicians who are not participating in the APM Entity. We would plan to communicate to each APM Entity the MIPS eligible clinicians who are included in the APM Entity group in advance of the applicable MIPS data submission deadline for the MIPS performance period.

Under the Shared Savings Program, each ACO is formed by a collection of Medicare-enrolled TINs (ACO participants). Pursuant to our regulation at 42 CFR 425.118, all Medicare enrolled individuals and entities that have reassigned their rights to receive Medicare payment to the TIN of the ACO participant must agree to participate in the ACO and comply with the requirements of the Shared Savings Program. Because all providers and suppliers that bill through the TIN of an ACO participant are required to agree to participate in the ACO, all MIPS eligible clinicians that bill through the TIN of an ACO participant are considered to be participating in the ACO. For purposes of the APM scoring standard, the ACO would be the APM Entity. The Shared Savings Program has established criteria for determining the list of eligible clinicians participating under the ACO, and we would use the same criteria for determining the list of MIPS eligible clinicians included in the APM Entity group for purposes of the APM scoring standard.

We recognize that there may be scenarios in which MIPS eligible clinicians may change TINs, use more than one TIN for billing Medicare, change their APM participation status, and/or change other practice affiliations during a performance period. Therefore, we propose that only those MIPS eligible clinicians who are listed as participants in the APM Entity in a MIPS APM on December 31 (the last day of the proposed performance period) would be considered part of the APM Entity group for purposes of the APM scoring standard. Consequently, MIPS eligible clinicians who are not listed as participants of an APM Entity in a MIPS APM at the end of the performance period would need to submit data to MIPS through one of the MIPS data submission mechanisms and would have their performance assessed either as individual MIPS eligible clinicians or as a group for all four performance categories. For example, a MIPS eligible clinician who participates in the APM Entity on January 1, 2017 and leaves the APM Entity on June 15, 2017 would need to submit data to MIPS using one of the MIPS data submission mechanisms and would have their performance assessed either as individual MIPS eligible clinicians or as a group. This approach for defining the applicable group of MIPS eligible clinicians is consistent with our proposal for identifying eligible clinician groups for purposes of QP determinations outlined in section II.F.5.b. of this proposed rule; the group of eligible clinicians CMS uses for purposes of a QP determination would be the same as that used for the APM scoring standard. This would be an annual process for each MIPS performance period. We propose to calculate one MIPS CPS for each APM Entity group, and that MIPS CPS would be applied to all MIPS eligible clinicians in the group. As previously explained in section II.E.7. of this proposed rule, the MIPS payment adjustment would be applied at the TIN/NPI level for each of the MIPS eligible clinicians in the APM Entity group.

(5) MIPS Eligible Clinicians Not Participating in a MIPS APM

The APM Entity group used for purposes of the APM scoring standard would be the same APM Entity group used for QP determinations under section II.F.5 of this proposed rule, except in the instances of APMs that do not meet the criteria to be MIPS APMs, as discussed in section II.E.5.h.(1) of this proposed rule. Examples of APMs that would not meet criteria to be MIPS APMs are those that do not have MIPS eligible clinicians as participants under the APM, or do not tie payment to cost/utilization and quality measures. We propose that the APM scoring standard would not apply to MIPS eligible clinicians participating in APMs that are not MIPS APMs. MIPS eligible clinicians who participate in an APM that is not a MIPS APM, would submit data to MIPS and have their performance assessed either as an individual MIPS eligible clinician or group as described in section II.E.2. of this proposed rule. Some APMs may involve certain types of MIPS eligible clinicians that are affiliated with an APM Entity but not included in the APM Entity group because they are not participants of the APM Entity. We propose that even if the APM meets the criteria to be a MIPS APM, MIPS eligible clinicians who are not included in the list of participants would not be considered part of the APM Entity group for purposes of the APM scoring standard. For instance, MIPS eligible clinicians in the Comprehensive Care for Joint Replacement Model might be involved in the APM through a business arrangement with the APM Entity (the inpatient hospital) but are not directly tied to beneficiary attribution, quality measurement, or care improvement activities under the APM. Additionally, we propose that if a MIPS eligible clinician participates in an APM Entity during the MIPS performance period but is no longer a participant in the APM Entity group on the last day of the Start Printed Page 28237performance period, the MIPS eligible clinician must submit either individual or group level data to MIPS. CMS will publish the list of MIPS APMs prior to the beginning of the MIPS performance period on the CMS Web site.

(6) APM Entity Group Scoring for the MIPS Performance Categories

As mentioned previously, section 1848(q)(3)(A) of the Act requires the Secretary to establish performance standards for the measures and activities under the following performance categories: (1) Quality; (2) resource use; (3) clinical practice improvement activities; and (4) advancing care information. We propose at § 414.1370 to calculate one CPS that is applied to the billing TIN/NPI combination of each MIPS eligible clinician in the APM Entity group. Therefore, each APM Entity group (for example, the MIPS eligible clinicians in a Shared Savings Program ACO or an Oncology Care Model practice) would receive a score for each of the four performance categories according to the proposals described in this section of the proposed rule, and we would calculate one CPS for the group. The APM Entity group score would be applied to each MIPS eligible clinician in the group, and subsequently used to develop the MIPS payment adjustment that is applicable for each MIPS eligible clinician in the group. Thus the APM Entity group score and the participating MIPS eligible clinician score are the same. For example, in the Shared Savings Program, the MIPS eligible clinicians in each ACO would be an APM Entity group. That group would receive a single CPS that would be applied to each of its participating MIPS eligible clinicians. Similarly, in the Oncology Care Model, the MIPS eligible clinicians in each oncology practice would be an APM Entity group. That group would receive a single CPS that would be applied to each of the MIPS eligible clinicians in the group. We note that this APM Entity group CPS is not used to evaluate eligible clinicians or the APM Entity for purposes of incentives within the APM, shared savings payments, or other potential payments under the APM, and we currently do not foresee APMs that would use the CPS for purposes of evaluation within the APM. Rather the APM Entity group CPS would be used only for the purposes of the APM scoring standard under MIPS for the first MIPS performance period. As proposed in this rule, all MIPS eligible clinicians listed as participating in the APM Entity on the last day of the performance period would be part of the APM Entity group and thus receive the same CPS. It should be noted that although we propose that the APM scoring standard only applies to participants in MIPS APMs, MIPS eligible clinicians that participate in an APM (including but not limited to a MIPS APM) and submit either individual or group level data to MIPS may earn a minimum score of 50 percent of the highest potential CPIA performance category score as long as such MIPS eligible clinicians are on the list of participants for an APM and are identifiable by the APM participant identifier.

Several commenters on the MIPS and APMs RFI suggested, and we generally agree, that MIPS eligible clinicians who collaborate under an APM Entity to accomplish the APM's goals should be treated as a group under MIPS and receive the same CPS. Furthermore, we want to avoid situations in which different MIPS eligible clinicians in the same APM Entity group receive different MIPS scores. APM Entities have a goal of collective success under the terms of the APM, so having a variety of differing MIPS adjustments for eligible clinicians within that collective unit would undermine the intent behind the APM to test a departure from a purely fee-for-service system based on independent clinician activity. Lastly, we believe that measurement of the performance for MIPS at the APM Entity level for eligible clinicians participating in MIPS APMs will result in more statistically valid performance scores for these eligible clinicians because the scores are aggregated to represent a larger group of MIPS eligible clinicians.

We propose, for the first MIPS performance period, a specific scoring and reporting approach for the MIPS eligible clinicians participating in MIPS APMs, which would include the Shared Savings Program, the Next Generation ACO Model, and other APMs that meet the criteria proposed above for a MIPS APM. Specifically, we propose that APM quality measure data submitted through the CMS Web Interface by ACOs participating in the Shared Savings Program and the Next Generation ACO Model would be used to evaluate performance for the MIPS quality performance category. We believe this is appropriate because all MIPS eligible clinicians that use the CMS Web Interface as their quality measure submission mechanism, e.g., MIPS eligible clinicians that report as a group and MIPS APM eligible clinicians that report as an APM Entity group, submit data on the same quality measures. Both the Shared Savings Program and the Next Generation ACO Model use additional quality measures for the purpose of APM performance assessment, but only the measures submitted to the CMS Web Interface would be used to evaluate performance for the MIPS quality performance category. Therefore, other measures that are required by the APM to assess APM quality performance will continue to be used for APM performance assessment only and not included in the MIPS quality performance category scoring. We also propose that MIPS eligible clinicians participating in MIPS APMs that do not use the CMS Web Interface as the mechanism for submitting APM quality data would not submit quality measure data to MIPS for the MIPS quality performance category until the second MIPS performance period (2018). In this section of the rule, we describe the APM Entity data submission requirements and propose a scoring approach for each of the MIPS performance categories for specific MIPS APMs (the Shared Savings Program, Next Generation ACO Model, and all other MIPS APMs).

Beginning with the first MIPS performance period all Shared Savings Program ACOs would submit their quality measures to MIPS using the CMS Web Interface through the same process that they use to report to the Shared Savings Program and be scored as they normally would under Shared Savings Program rules. Shared Savings Program ACOs have used the CMS Web Interface for submitting their quality measures since the program's inception, making this a familiar data submission process. We also propose that the Shared Savings Program ACO quality measure data that is submitted through the CMS Web Interface will be submitted only once but will be used for two purposes. The Shared Savings Program quality measure data reported to the CMS Web Interface would be used by CMS to calculate the MIPS quality performance category score at the APM Entity group (ACO) level. The Shared Savings Program quality performance data that is not submitted to the CMS Web Interface, for example the CAHPS survey and other claims measures would not be included in the MIPS APM quality performance category score. We believe this will reduce the reporting burden for Shared Savings Program MIPS eligible clinicians by requiring quality measure data to be submitted only once and used for both programs. The MIPS quality Start Printed Page 28238performance category requirements and performance benchmarks for quality measures submitted via the CMS Web Interface would be used to determine the MIPS quality performance category score at the ACO level for the APM Entity group.

We believe that no waivers are necessary here because the quality measures submitted via the CMS Web Interface under the Shared Savings Program are also MIPS quality measures and will be scored under MIPS performance standards. In the event that Shared Savings Program quality measures depart from MIPS measures in the future, we will address such changes including whether further waivers are necessary at such a time in future rulemaking.

We propose that for the first MIPS performance period, we will not assess MIPS eligible clinicians participating in the Shared Savings Program (the MIPS APM) under the resource use performance category. We propose this approach because: (1) Eligible clinicians participating in the Shared Savings Program are already subject to cost and utilization performance assessments under the APM; (2) the Shared Savings Program measures resource use in terms of an objective, absolute total cost of care expenditure benchmark for a population of attributed beneficiaries, and participating ACOs may share savings and/or losses based on that standard, whereas the MIPS resource use measures are relative measures such that clinicians are graded relative to their peers, and therefore different than assessing total cost of care for a population of attributed beneficiaries; and (3) the beneficiary attribution methodologies for measuring resource use under the Shared Savings Program and MIPS differ, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many TINs comprise an ACO. We believe that with an APM Entity's finite resource for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through an APM must take priority to ensure that the goals and program evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across Shared Savings Program and MIPS assessments—due to the differences in attribution, the inclusion in MIPS of episode-based measures that do not reflect the total cost of care, and the objective versus relative assessment factors listed above—creates uncertainty for eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the Shared Savings Program.

For example, Shared Savings Program ACOs are held accountable for expenditure benchmarks that reflect the total Medicare Parts A and B spending for their assigned beneficiaries, whereas many of the proposed MIPS resource use measures focus on spending for particular episodes of care or clinical conditions. For the reasons stated above, we consider it a programmatic necessity that the Shared Savings Program has the ability to structure its own measurement and payment for performance on total cost of care independent from other incentive programs such as the resource use performance category under MIPS. Thus, we propose to reduce the MIPS resource use performance category weight to zero for all MIPS eligible clinicians in APM Entities participating in the Shared Savings Program. Accordingly, under section 1899(f) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Shared Savings Program—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the resource use performance category. With the proposed reduction of the resource use performance category weight to zero, we believe it would be unnecessary specify and use resource use measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1899(f) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Shared Savings Program—the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, resource use measures in calculating the MIPS CPS for such MIPS eligible clinicians.

Given the proposal to waive requirements under section 1848(q)(5)(E)(i)(II) of the Act in order to reduce the weight of the resource use performance category to zero, we must subsequently specify how that weight would be redistributed among the remaining performance categories in order to maintain a total weight of 100 percent. We propose to redistribute the resource use performance category weight to both the CPIA and advancing care information performance categories as specified in Table 12. The MIPS resource use performance category is proposed to have a weight of 10 percent for the first performance period. Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories, and its weight is scheduled to be reduced from 50 to 30 percent over time, we propose to evenly redistribute the 10 percent resource use performance category weight to the CPIA and advancing care information performance categories so that the distribution does not change the relative weight of the quality performance category in the opposite direction of its future state. The redistributed resource use performance category weight of 10 percent would result in a 5 percentage point increase (from 15 to 20 percent) for the CPIA performance category and a 5 percentage point increase (from 25 to 30 percent) for the advancing care information performance category. We invite comments on the proposed weights and specifically, whether we should increase the MIPS quality performance category weight.

We understand that as the MIPS resource use performance category evolves over time, there might be greater potential for alignment and less potential duplication or conflict with MIPS resource use measurement for MIPS eligible clinicians participating in APMs such as the Shared Savings Program. We will continue to monitor and consider how we might incorporate an assessment in the MIPS resource use performance category into the APM scoring standard for MIPS eligible clinicians participating in the Shared Savings Program. We also understand that reducing the resource use performance category weight to zero and redistributing the weight to the CPIA and advancing care information performance categories could, to the extent that CPIA and advancing care information scores are higher than the scores these MIPS eligible clinicians would have received under resource use, result in higher average scores for MIPS eligible clinicians participating in the Shared Savings Program. We seek comment on the possibility of assigning a neutral score to the Shared Savings Program APM Entity groups for the resource use performance category to moderate MIPS composite performance scores for APM Entities participating in the Shared Savings Program. We also generally seek comment on our proposed policy, and on whether and how we should incorporate the resource use performance category into the APM scoring standard under MIPS for eligible Start Printed Page 28239clinicians participating in the Shared Savings Program for future years.

We propose that MIPS eligible clinicians participating in the Shared Savings Program would submit data for the MIPS CPIA and advancing care information performance categories through their respective ACO participant billing TINs independent of the Shared Savings Program ACO. Pursuant to section 1848(q)(5)(C)(ii) of the Act, all ACO participant group billing TINs would receive a minimum of one half of the highest possible score for the CPIA performance category. Additionally, pursuant to section 1848(q)(5)(C)(i) of the Act, any ACO participant TIN that is determined to be a patient-centered medical home or comparable specialty practice will receive the highest potential score for the CPIA performance category. The scores from all of the ACO participant billing TINs would be averaged to a weighted mean MIPS APM Entity group level score. We propose to use a weighted mean in computing the overall CPIA and advancing care information quality performance category score in order to account for difference in the size of each TIN and to allow each TIN to contribute to the overall score based on its size. Then all MIPS eligible clinicians in the APM Entity group, as identified by their APM participant identifiers, would receive that APM Entity score. The weights used for each ACO participant billing TIN would be the number of MIPS eligible clinicians in that TIN. Because all providers and suppliers that bill through the TIN of an ACO participant are required to agree to participate in the ACO, all MIPS eligible clinicians that bill through the TIN of an ACO participant are considered to be participating in the ACO. Any Shared Savings Program ACO participant billing TIN that does not submit data for the MIPS CPIA and/or advancing care information performance categories would contribute a score of zero for each performance category for which it does not report; and that score would be incorporated into the resulting weighted average score for the Shared Savings Program ACO. All MIPS eligible clinicians in the ACO (the APM Entity group) would receive the same score that is calculated at the ACO level (the APM Entity).

In this example, each eligible clinician participating in the APM Entity (Shared Savings Program ACO) would receive a CPIA performance category score of 78.5 and an advancing care information performance category score of 85. We recognize that the Shared Savings Program eligible clinicians participate as a complete TIN because all of the eligible clinicians that have reassigned their Medicare billing rights to the TIN of an ACO participant must agree to participate in the Shared Savings Program. This is different from other APMs, which may include APM Entity groups with eligible clinicians who share a billing TIN with other eligible clinicians who do not participate in the APM Entity. We seek comment on a possible alternative approach in which CPIA and advancing care information performance category scores would be applied to all MIPS eligible clinicians at the individual billing TIN level, as opposed to aggregated to the ACO level, for Shared Savings Program participants. If MIPS APM scores were applied to each TIN in an ACO at the TIN level, we would also likely need to permit those TINs to make the Partial QP election, as discussed elsewhere in this proposed rule, at the TIN level. We propose that under the APM scoring standard, the ACO-level APM Entity group score would be applied to each participating MIPS eligible clinician to determine the MIPS payment adjustment. We believe calculating the score at the APM Entity level mirrors the way APM participants are assessed for their shared savings and other incentive payments in the APM, but we understand there may be reasons why a group TIN, particularly one that believes it would achieve a higher score than the weighted average APM Entity level score, would prefer to be scored in the CPIA and advancing care information performance categories at the level of the group billing TIN rather than the ACO (APM Entity level). Therefore, we seek comment as to whether Shared Savings Program ACO eligible clinicians should be scored at the ACO level or the group billing TIN level for the CPIA and advancing care information performance categories. In Start Printed Page 28240Table 12, we provide a summary of the proposed MIPS data submission requirements and scoring under the APM scoring standard for MIPS eligible clinicians participating in a Shared Savings Program ACO.

Beginning with the first MIPS performance period, all Next Generation ACO Model ACOs would submit their ACO quality measures to MIPS using the CMS Web Interface through the same process that they use to report to the Next Generation ACO Model and be scored as they normally would under Next Generation ACO Model rules. Next Generation ACO Model ACOs will have used the CMS Web Interface for submitting their quality measures since the model's inception and would most likely continue to use the CMS Web Interface as the submission method in future years. We also propose that the Next Generation ACO Model quality measure data that is submitted through the CMS Web Interface will be submitted only once but will be used for two purposes. The Next Generation ACO Model quality measure data reported to the CMS Web Interface would be used by CMS to calculate the MIPS APM quality performance score. The MIPS quality performance category requirements and performance benchmarks for reporting quality measures via the CMS Web Interface would be used to determine the MIPS quality performance category score at the ACO level for the APM Entity group. The Next Generation ACO Model quality performance data that is not submitted to the CMS Web Interface, for example the CAHPS survey and other claims measures would not be included in the MIPS APM quality performance score. The MIPS APM quality performance category score would be calculated using only quality measure data submitted through the CMS Web Interface, while the quality reporting requirements and performance benchmarks calculated by the Next Start Printed Page 28241Generation ACO Model would continue to be used to assess the ACO under the APM specific requirements. We believe this approach would reduce the reporting burden to Next Generation ACO Model participants by requiring quality measure data to be submitted only once and used for both MIPS and the Next Generation ACO Model.

We believe that no waivers are necessary here because the quality measures submitted via the CMS Web Interface under the Next Generation ACO Model are MIPS quality measures and will be scored under MIPS performance standards. In the event that Next Generation ACO Model quality measures depart from MIPS measures in the future, we will address such changes, including whether further waivers are necessary, at such a time in future rulemaking.

We propose that for the first MIPS performance period, we will not assess MIPS eligible clinicians in the Next Generation ACO Model participating in the MIPS APM under the resource use performance category. We propose this approach because: (1) MIPS eligible clinicians participating in the Next Generation ACO Model are already subject to cost and utilization performance assessments under the APM; (2) the Next Generation ACO Model measures resource use in terms of an objective, absolute total cost of care expenditure benchmark for a population of attributed beneficiaries, and participating ACOs may share savings and/or losses based on that standard, whereas the MIPS resource use measures are relative measures such that clinicians are graded relative to their peers and therefore different than assessing total cost of care for a population of attributed beneficiaries; and (3) the beneficiary attribution methodologies for measuring resource use under the Next Generation ACO Model and MIPS differ, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many eligible clinicians comprise an ACO. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through the Next Generation ACO Model must take priority to ensure that the goals and model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across the Next Generation ACO Model and MIPS assessments—due to the differences in attribution, the inclusion in MIPS of episode-based measures that do not reflect the total cost of care, and the objective versus relative assessment factors listed above—creates uncertainty for eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the Next Generation ACO Model. For example, Next Generation ACOs are held accountable for expenditure benchmarks that reflect the total Medicare Parts A and B spending for their attributed beneficiaries, whereas many of the proposed MIPS resource use measures focus on spending for particular episodes of care or clinical conditions. For all the reasons stated above, we propose to reduce the MIPS resource use performance category weight to zero for all MIPS eligible clinicians participating in the Next Generation ACO Model. Accordingly, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the resource use performance category. With the proposed reduction of the resource use performance category weight to zero, we believe it would be unnecessary to specify and use resource use measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Next Generation ACO Model—the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, resource use measures in calculating the MIPS CPS for such eligible clinicians.

Given the proposal to waive requirements under section 1848(q)(5)(E) of the Act in order to reduce the weight of the resource use performance category to zero, we must subsequently specify how that weight would be redistributed among the remaining performance categories in order to maintain a total weight of 100 percent. We propose to redistribute the resource use performance category weight to both the CPIA and advancing care information performance categories as specified in Table 13. The MIPS resource use performance category is proposed to have a weight of 10 percent. Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories and its weight is scheduled to be reduced from 50 to 30 percent over time, we propose to evenly redistribute the 10 percent resource use weight to the CPIA and advancing care information performance categories so that the distribution does not change the relative weight of the quality performance category in the opposite direction of its future state. The redistributed resource use performance category weight of 10 percent would result in a 5 percentage point increase (from 15 to 20 percent) for the CPIA performance category and a 5 percentage point increase (from 25 to 30 percent) for the advancing care information performance category. We invite comments on the proposed redistributed weights and specifically on whether we should also increase the MIPS quality performance category weight.

We understand that as the MIPS resource use performance category evolves over time, there might be greater potential for alignment and less potential duplication or conflict with MIPS resource use measurement for MIPS eligible clinicians participating in MIPS APMs such as the Next Generation ACO Model. We will continue to monitor and consider how we might incorporate an assessment in the MIPS resource use performance category into the APM scoring standard for the Next Generation ACO Model. We also understand that reducing the resource use weight to zero and redistributing the weight to the CPIA and advancing care information performance categories could, to the extent that CPIA and advancing care information scores are higher than the scores MIPS eligible clinicians would have received under resource use, result in higher average scores for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO Model. We seek comment on the possible alternative of assigning a neutral score to APM Entity groups (ACOs) participating in the Next Generation ACO model for the resource use performance category in order to moderate APM Entity scores. We also generally seek comment on our proposed policy, and on whether and how we should incorporate the resource use performance category into the APM scoring standard for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO model for future years.Start Printed Page 28242

We propose that all MIPS eligible clinicians participating in the Next Generation ACO Model would submit data for the CPIA and advancing care information performance categories. Eligible clinicians in the Next Generation ACO Model may belong to a billing TIN that includes non-participating APM eligible clinicians. Therefore for both CPIA and the advancing care information performance category, we propose that these MIPS eligible clinicians would submit individual level data to MIPS and not group level data.

For both the CPIA and advancing care information performance categories, the scores from all of the individual MIPS eligible clinicians in the APM Entity group would be aggregated to the APM Entity level and averaged for a mean score. Any individual MIPS eligible clinicians that do not report the CPIA or advancing care information performance category would contribute a score of zero for that performance category in the calculation of the APM Entity score. All MIPS eligible clinicians in the APM Entity group would receive the same APM Entity score.

As noted above, because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories, we propose to evenly redistribute the 10 percent resource use performance category weight to the CPIA and advancing care information performance categories. Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible clinicians who are in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period shall be given the highest potential score for the CPIA performance category. Accordingly, a MIPS eligible clinician participating in an APM Entity that meets the definition of a patient-centered medical home or comparable specialty practice, as discussed in section II.E.5.f. of this proposed rule, will receive the highest potential score. Additionally, section 1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for CPIA.

For the APM scoring standard for the first MIPS performance period, we propose to weight the CPIA and advancing care information performance categories for the Next Generation ACO Model in the same way that we propose to weight those categories for the Shared Savings Program: 20 percent and 30 percent for CPIA and advancing care information, respectively. We seek comment on our proposals for reporting and scoring the CPIA and advancing care information performance categories under the APM scoring standard. In particular, we seek comment on the appropriate weight distributions in the first year.

In Table 13, we provide a summary of the proposed MIPS data submission and scoring under the APM scoring standard for MIPS eligible clinicians participating in a Next Generation ACO.

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(13) MIPS APMs Other Than the Shared Savings Program and the Next Generation ACO Model—Quality Performance Category Scoring Under the APM Scoring Standard

For MIPS APMs other than the Shared Savings Program and the Next Generation ACO Model, we propose that eligible clinicians or APM Entities would submit APM quality measures under their respective MIPS APM as usual, and those eligible clinicians or APM Entities would not also be required to submit quality information under MIPS. Current MIPS APMs have requirements regarding the number of quality measures, measure specifications, as well as the measure reporting method(s) and frequency of reporting, and have an established mechanism for submission of these measures to CMS. We believe there are operational considerations and constraints that would prevent us from being able to use the quality measure data from some MIPS APMs for the purpose of satisfying the MIPS data submission requirements for the quality performance category in the first performance period. For example, some current APMs use a quality measure data collection system or vehicle that is separate and distinct from the MIPS systems. We do not believe there is sufficient time to adequately implement changes to the current APM quality measure data collection timelines and infrastructure to conduct a smooth hand-off to the MIPS system that would enable use of APM quality measure data to satisfy the MIPS quality performance category requirements in the first MIPS performance period. As we have noted, we are concerned about subjecting MIPS eligible clinicians who participate in MIPS APMs to multiple performance assessments—under MIPS and under the APMs—that are not necessarily aligned and that could potentially undermine the validity of testing or performance evaluation under the APM. As stated previously, our goal is to reduce MIPS eligible clinician reporting burden by not requiring APM participants to report quality data twice to CMS, and to avoid misaligned performance incentives. Therefore, we propose that, for the first MIPS performance period only, for MIPS eligible clinicians participating in APM Entity groups in MIPS APMs (other than the Shared Savings Program or the Next Generation ACO Model), we would reduce the weight for the quality performance category to zero. We believe it is necessary to do this because CMS requires additional time to make adjustments in systems and processes related to the submission and collection of APM quality measures in order to align APM quality measures with the MIPS, and ensure APM quality measure data can be submitted in a time and in a manner sufficient for use in assessing quality performance under MIPS and under the APM. Additionally, due to the implementation of a new program that does not account for non-MIPS Start Printed Page 28244measures sets, the operational complexity of connecting APM performance to valid MIPS quality performance category scores in the necessary timeframe, as well as the uncertainty of the validity and equity of scoring results could unintentionally undermine the quality performance assessments in MIPS APMs. Finally, for purposes of performing valid evaluations of MIPS APMs, we must reduce the number of confounding factors to the extent feasible, which, in this case, would include reporting and assessment on non-APM quality measures. Thus, we propose to waive certain requirements of section 1848(q) of the Act for the first MIPS performance year to avoid risking adverse operational or program evaluation consequences for MIPS APMs while we work toward incorporating MIPS APM quality measures into MIPS scoring for future MIPS performance periods without. Accordingly, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(I) of the Act that specifies the scoring weight for the quality performance category. With the proposed reduction of the quality performance category weight to zero, we believe it would be unnecessary to establish an annual final list of quality measures as required under section 1848(q)(2)(D) of the Act, or to specify and use quality measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i) and 1848(q)(2)(A)(i) of the Act to establish a final list of quality measures (using certain criteria and processes); and to specify and use, respectively, quality measures in calculating the MIPS CPS, for these MIPS eligible clinicians.

We anticipate that beginning in the second MIPS performance period, the APM quality measure data submitted during the MIPS performance period to us would be used to derive a MIPs quality performance score for APM Entities in all APMs that meet criteria for application of the APM scoring standard. We anticipate that it may be necessary to propose policies and waivers of different requirements of the statute—such as one for section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality measures in the quality performance category score—through future rulemaking. We expect that by the second MIPS performance period we will have had sufficient time to resolve operational constraints related to use of separate quality measure systems and adjust quality measure data submission timelines. Therefore, beginning with the second MIPS performance period, we anticipate that through use of the waiver authority under section 1115A(d)(1) of the Act, the quality measure data for APM Entities for which the APM scoring standard applies would be used for calculation of a MIPS quality performance score in a manner specified in future rulemaking. We seek comment on this transitional approach to use APM quality measures for the MIPS quality performance category for purposes of the APM scoring standard under MIPS in future years.

(14) MIPS APMs Other Than the Shared Savings Program and Next Generation ACO—Resource Use Performance Category Scoring Under the APM Scoring Standard

For the first MIPS performance period, we propose that, for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO, to reduce the weight of the resource use performance category to zero. We propose this approach because: (1) APM Entity groups are already subject to cost and utilization performance assessments under MIPS APMs; (2) MIPS APMs usually measure resource use in terms of total cost of care, which is a broader accountability standard inherently encompasses the purpose of the claims-based measures that have relatively narrow clinical scopes, and MIPS APMs that do not measure resource use in terms of total cost of care may depart entirely from MIPS measures; and (3) the beneficiary attribution methodologies differ for measuring resource use under APMs and MIPS, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many eligible clinicians comprise an APM Entity. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through an APM must take priority to ensure that the goals and model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across APM and MIPS assessments creates uncertainty for MIPs eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of an APM. Accordingly, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the resource use performance category.

With the proposed reduction of the resource use performance category weight to zero, we believe it would be unnecessary to specify and use resource use measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirements under section under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, resource use measures in calculating the MIPS CPS for such eligible clinicians.

Given the proposal to waive requirements of section 1848(q) of the Act to reduce the weight of the quality and resource use performance categories to zero, we must subsequently specify how those weights would be redistributed among the remaining CPIA and advancing care information categories in order to maintain a total weight of 100 percent. We propose to redistribute the quality and the resource use performance category weights as specified in Table 14.

We understand that as the resource use performance category evolves, the rationale we discussed earlier for establishing a weight of zero for this performance category might not be applicable in future years. We seek comment on whether and how we should incorporate the resource use performance category into the APM scoring standard under MIPS. We also understand that reducing the quality and resource use performance category weight to zero and redistributing the weight to the CPIA and advancing care information performance categories could, to the extent that CPIA and advancing care information scores are higher than the scores MIPS eligible clinicians would have received under resource use, result in higher average scores for MIPs eligible clinicians in Start Printed Page 28245APM Entity groups participating in MIPS APMs. We seek comment on the possible alternative of assigning a neutral score to MIPS eligible clinicians in APM Entity groups participating in MIPS APMs for the quality and resource use performance category in order to moderate APM Entity scores.

(15) MIPS APMs Other Than the Shared Savings Program and Next Generation ACO Model—CPIA and Advancing Care Information Performance Category Scoring Under the APM Scoring Standard

We propose that all MIPS eligible clinicians participating in a MIPS APM other than the Shared Savings Program or the Next Generation ACO would submit data for the CPIA and Advancing Care Information performance categories. We propose that these MIPS eligible clinicians would submit data for both the CPIA and advancing care information performance categories as individual MIPS eligible clinicians. MIPS eligible clinicians in these other APMs may belong to a billing TIN that includes MIPs eligible clinicians that do not participate in the APM. Therefore for both CPIA and the advancing care information performance category, we propose that these MIPS eligible clinicians submit individual level data to MIPS and not group level data.

For both the CPIA and advancing care information performance categories, the scores from all of the individual MIPS eligible clinicians in the APM Entity group would be aggregated to the APM Entity level and averaged for a mean score. Any individual MIPS eligible clinicians that do not submit data for the CPIA or advancing care information performance category would contribute a score of zero for that performance category in the calculation of the APM Entity score. All MIPS eligible clinicians in the APM Entity group would receive the same APM Entity group score.

Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible clinicians who are in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period shall be given the highest potential score for the CPIA performance category. Accordingly, a MIPS eligible clinician in an APM Entity group that meets the definition of a patient-centered medical home or comparable specialty practice, as discussed in section II.E.5.f. of this proposed rule, will receive the highest potential score. Additionally, section 1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for CPIA. We acknowledge that using this increased weight for CPIA may make it easier in the first performance period to attain a higher MIPS score. We do not have historical data to assess the range of scores under CPIA because this is the first time such activities are being assessed in such a manner.

With respect to the advancing care information performance category, we believe that MIPS eligible clinicians participating in MIPS APMs would be using certified health IT and other health information technology to coordinate care and deliver better care to their patients. Most MIPS APMs encourage participants to use health IT to perform population management, monitor their own quality improvement activities and, better coordinate care for their patients in a way that aligns with the goals of the advancing care information performance category. We want to ensure that where we propose reductions in weights for other MIPS performance categories, such weights are appropriately redistributed to the advancing care information performance category.

Therefore, for the first MIPS performance period, we propose that the weights for the CPIA and advancing care information performance categories would be 25 percent and 75 percent, respectively. We seek comment on our proposals for reporting and scoring the CPIA and advancing care information performance categories under the APM scoring standard. In particular, we seek comment on the appropriate weight distributions in the first year and subsequent years when we anticipate incorporating assessment in the quality performance category for all MIPS eligible clinicians participating in MIPS APMs.

Table 14 shows the performance category scoring and weights for other APMs for which the APM scoring standard applies.

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(14) APM Entity Data Submission Method

Presently, CMS requires MIPS APMs to either use the CMS Web Interface or another data submission mechanism for submitting data on the quality measures for purposes of the APM. We are not currently proposing to change the method used by APM Entities to submit their data on quality measures to CMS for purposes of MIPS. Therefore, we expect that APM Entities like the Shared Savings Program ACOs would continue to submit their data on quality measures using the CMS Web Interface data submission mechanism. Similarly, participants in the Comprehensive ESRD Care (CEC) Initiative would continue to submit their quality measures to CMS using the Quality Measures Assessment Tool (QMAT) for purposes of the CEC quality performance assessment under the APM. All eligible clinicians in APM Entities participating in MIPS APMs would be required to use one of the proposed MIPS data submission mechanisms to submit data for the CPIA and advancing care information performance categories.

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(15) MIPS APM Performance Feedback

For the first MIPS performance feedback specified under section 1848(q)(12) of the Act to be published by July 1, 2017, we propose that all MIPS eligible clinicians participating in MIPS APMs would receive the same historical information prepared for all MIPS eligible clinicians except the report would indicate that the historical information provided to such MIPS eligible clinicians is for informational purposes only. MIPS eligible clinicians participating in APMs have been evaluated for performance only under the APM. Thus, historical information may not be representative of the scores that these MIPS eligible clinicians would receive under MIPS.

For MIPS eligible clinicians participating in MIPS APMs, we propose that the MIPS performance feedback would consist only of the scores applicable to the APM Entity group for the specific MIPS performance period. For example, the MIPS eligible clinicians participating in the Shared Savings Program and Next Generation ACO Model would receive performance feedback for the quality, CPIA, and advancing care information performance categories for the 2017 performance period. Because these MIPS eligible clinicians would not be assessed for the resource use performance category, information on MIPS performance scores for the resource use performance category would not be applicable to these MIPS eligible clinicians.

We also propose that, for the Shared Savings Program the performance feedback would be available to the eligible clinicians participating in the Shared Savings Program at the group billing TIN level. For the Next Generation ACO Model we propose that the performance feedback would be available to all MIPS eligible clinicians participating in the MIPS APM Entity.

We propose that in the first MIPS performance period, the MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model would receive performance feedback for the CPIA and advancing care information only, as they would not be assessed under the quality or resource use performance categories. The information such as MIPS measure score comparisons for the quality and resource use performance categories would not be applicable to these MIPS eligible clinicians because no such comparative data would exist. We propose the performance feedback for all other MIPS eligible clinicians participating in APMs would be available for each MIPS eligible clinician that submitted MIPS data for these performance categories under their respective APM Entities. We invite comment on these proposals.

6. MIPS Composite Performance Score Methodology

By incentivizing quality and value for all eligible clinicians, MIPS creates a new mechanism for calculating eligible clinician payments. To implement this vision, we propose a scoring methodology that allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians. Further, we propose a scoring methodology that is meaningful, understandable and flexible for all MIPS eligible clinicians. Our proposed methodology allows for multiple pathways to success with flexibility for the variety of practice types and reporting options. First, we have proposed multiple ways that MIPS eligible clinicians may submit data to MIPS for the quality performance category. Second, we generally do not propose “all-or-nothing” reporting requirements for MIPS. Third, bonus points would be available for reporting high priority measures and electronic reporting of quality data. Recognizing that MIPS is a new program, we also outline proposals which we believe are operationally feasible for us to implement in the first year, while maintaining our longer-term vision, as well as Congress' vision.

Section 1848(q) of the Act requires the Secretary to: (1) Develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for a performance period for a year; (2) using the methodology, provide a composite performance score for each MIPS eligible clinician for each performance period; and (3) use the CPS of the MIPS eligible clinician for a performance period to determine and apply a MIPS adjustment factor (and, as applicable, an additional MIPS adjustment factor) to the MIPS eligible clinician for the MIPS payment year. Section II.E.5 of this rule proposes the measures and activities for each of the four MIPS performance categories: Quality, resource use, CPIA, and advancing care information. This section proposes the performance standards for the measures and activities for each of the four performance categories under section 1848(q)(3) of the Act, the methodology for determining a score for each of the four performance categories (referred to as a “performance category score”), and the methodology for determining a CPS under section 1848(q)(5) of the Act based on the scores determined for each of the four performance categories. The performance category score is defined at § 414.1305 as the assessment of each MIPS eligible clinician's performance on the applicable measures and activities for a performance category for a performance period based on the performance standards for those measures and activities. Section II.E.7. includes proposals for determining the MIPS adjustments factors based on the CPS.

As noted in section II.E.2., we propose to use multiple identifiers to allow MIPS eligible clinicians to be measured as individuals, or collectively as part of a group or an APM Entity group (an Start Printed Page 28248APM Entity participating in a MIPS APM). Further, in section II.E.5.a.2., we propose that data for all four MIPS performance categories would be submitted using the same identifier (either individual or group) and that the CPS would be calculated using the same identifier. The scoring proposals in this section II.E.6. would be applied in the same manner for either individual submissions, proposed as TIN/NPI, or for the group submissions using the TIN identifier. Unless otherwise noted, for purposes of this section, the term “MIPS eligible clinician” will refer to both individual and group reporting and scoring, but will not refer to an APM Entity group.

APM Entity group reporting and scoring for MIPS eligible clinicians participating in MIPS APMs are described in section II.E.5.h. of this proposed rule. All eligible clinicians that participate in APMs are considered MIPS eligible clinicians unless and until they are determined to be either QPs or Partial QPs who elect not to report under MIPS, and excluded from MIPS. For the APM scoring standard to apply to a MIPS eligible clinician, the eligible clinician must be listed as a participant in the APM Entity that participates in a MIPS APM as of December 31 of the performance period, as described in section II.E.5.h. CMS will publish a list of MIPS APMs on the CMS Web site in advance of the performance period.

MIPS eligible clinicians who participate in APMs that are not MIPS APMs would report to MIPS as an individual MIPS eligible clinician or group. Unless otherwise specified, the proposals in this section II.E.6 that relate to reporting and scoring of measures and activities do not affect the APM scoring standard.

Our rationale for our scoring methodology is grounded in the understanding that the MIPS scoring system is a complex system with numerous moving parts. Thus, we believe it is necessary to set up key parameters around scoring, including requiring MIPS eligible clinicians to report at the individual or group level across all performance categories and generally to submit information for a performance category using a single submission mechanism. Too many different permutations would create additional complexities that could create confusion amongst MIPS eligible clinicians as to what is and is not allowed.

(1) Policies That Apply Across Multiple Performance Categories

The detailed policies for scoring the four performance categories are described in this section II.E.6.a. of this rule. However, as the four performance categories collectively create a single MIPS CPS, there are some cross-cutting policies that we propose to apply to multiple performance categories.

(a) Performance Standards

Section 1848(q)(3)(A) of the Act requires the Secretary to establish performance standards for the measures and activities in the four MIPS performance categories. Section 1848(q)(3)(B) of the Act requires the Secretary, in establishing performance standards for measures and activities for the four MIPS performance categories, to consider historical performance standards, improvement, and the opportunity for continued improvement. We propose to define the term, performance standards, at § 414.1305 as the level of performance and methodology that the MIPS eligible clinician is assessed on for a MIPS performance period at the measures and activities level for all MIPS performance categories. We define the term, MIPS payment year at § 414.1305 as the calendar year in which MIPS payment adjustments are be applied. Performance standards for each performance category are proposed in more detail later in this section, II.E.6. MIPS eligible clinicians would know the actual performance standards in advance of the performance period, when possible. Further, each performance category is unified under the principle that MIPS eligible clinicians would know, in advance of the performance period, the methodology for determining the performance standards and the methodology that would be used to score their performance. Table 16 summarizes the performance standards, which are proposed in more detail in section II.E.6.a.

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(b) Unified Scoring System

Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for applicable measures and activities in each performance category applicable to the MIPS eligible clinician for a performance period. While MIPS has four different performance categories, we propose a unified scoring system that enables MIPS eligible clinicians, beneficiaries, and stakeholders to understand what is required for a strong performance in MIPS while being consistent with statutory requirements. We sought to keep the scoring as simple as possible, while providing flexibility for the variety of practice types and reporting options. We would incorporate the following characteristics into the proposed scoring methodologies for each of the four MIPS performance categories:

For the quality and resource use performance categories, all measures would be converted to a 10-point scoring system which provides a framework to universally compare different types of measures across different types of MIPS eligible clinicians. A similar point framework has been successfully implemented in several other CMS quality programs including the Hospital Value-Based Purchasing Program (HVBP).

The measure and activity performance standards would be published, where feasible, before the performance period begins, so that MIPS eligible clinicians can track their performance during the performance period. This transparency would make the information more actionable to MIPS eligible clinicians.

Unlike the PQRS or the EHR Incentive Program, we generally would not include “all-or-nothing” reporting requirements for MIPS. The methodology would score measures and activities that meet certain standards defined in section II.E.5 and this section. However, section 1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring methodology, MIPS eligible clinicians who fail to report on an applicable measure or activity that is required to be reported shall be treated as receiving the lowest possible score for the measure or activity. Therefore, MIPS eligible clinicians that fail to report specific measures or activities would receive zero points for each required measure or activity that they do not submit to MIPS.

The scoring system would ensure sufficient reliability and validity, by only scoring the measures that meet certain standards (such as required case minimum). The standards are described later in this section.

Performance at any level would receive points towards the performance category scores.

For the first year of MIPS, there are some minor differences in the proposed performance category scoring methodologies to account for differences in the maturity of the data collection systems and the measures and activities; however, we anticipate that the scoring in future years would continue to align and simplify. We request comment on the characteristics of the proposed unified scoring system.

We also propose at § 414.1325 that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending CPIA data, but a MIPS eligible clinician could not use two submission mechanisms for a single performance category, such as submitting three quality measures via claims and three quality measures via registry. We do intend to allow flexibility, for example, in rare Start Printed Page 28250situations where a MIPS eligible clinician submits data for a performance category via multiple submission mechanisms (for example, submits data for the quality performance category through a registry and QCDR), we would score all the options and use the highest performance category score for the eligible clinician.

In carrying out MIPS, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act. In addition, section 1848(q)(5)(B)(ii) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall encourage MIPS eligible clinicians to report on applicable measures under the quality performance category through the use of CEHRT and QCDRs. To encourage the use of QCDRs, we have created opportunities for QCDRs to report new and innovative quality measures. In addition, several CPIAs emphasize QCDR participation. Finally, we propose under section II.E.5.a. for QCDRs to be able to submit data on all MIPS performance categories. We believe these flexible options would allow MIPS eligible clinicians to meet the submission criteria for MIPS in a low burden manner, which in turn may positively affect their CPS.

In addition, section 1848(q)(5)(D) of the Act lays out the requirements for incorporating performance improvement into the MIPS scoring methodology beginning with the second MIPS performance period, if data sufficient to measure improvement is available. Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may be weighted higher than improvement. Stated generally, we consider achievement to mean how a MIPS eligible clinician performs compared to other MIPS eligible clinicians for each applicable measure and activity in a performance category, and improvement to mean how a MIPS eligible clinician performs compared to the MIPS eligible clinician's own previous performance on measures and activities in a performance category. Improvement would not be scored for the first year of MIPS, but we seek comment on how best to incorporate improvement scoring for all performance categories.

(c) Baseline Period

In other Medicare quality programs, such as the HVBP, we have adopted a baseline period that occurs prior to the performance period for a program year to measure improvement and to establish performance standards. We view the MIPS Program as necessitating a similar baseline period for the quality performance category. We intend to establish a baseline period for each performance period for a MIPS payment year to measure improvement for the quality performance category and to enable us to calculate performance standards that we can establish and announce prior to the performance period. As with the HVBP, we intend to adopt baseline periods that are as close as possible in duration to the performance period specified for a MIPS payment year. In addition, evaluating performance compared to a baseline period may enable other payers to incorporate MIPS benchmarks into their programs. For each MIPS payment year, we propose at § 414.1380 that the baseline period would be two years prior to the performance period for the MIPS payment year. Therefore, for the first MIPS payment year (CY 2019 payment adjustments), for the quality performance category, we propose that the baseline period would be calendar year 2015 which is 2 years prior to the proposed calendar year 2017 performance period. As discussed in section II.E.6.a.2.a. we propose to use performance in the baseline period to set benchmarks for the quality performance category, with the exception of new measures for which we would set the benchmarks using performance in the performance period. For the resource use performance category, we propose to set the benchmarks using performance in the performance period and not the baseline period, as discussed in section II.E.6.a.3. For the resource use performance category, we also have included an alternative proposal to set the benchmarks using performance in the baseline period. We define the term “measure benchmark” for the quality and resource use performance categories at § 414.1305 as the level of performance that the MIPS eligible clinician will be assessed on for a performance period at the measures level.

(2) Scoring the Quality Performance Category

In section II.E.5.b.3, we proposed multiple ways that MIPS eligible clinicians may submit data for the quality performance category to MIPS; however, we propose that the scoring methodology would be consistent regardless of how the data is submitted. In summary, we propose at § 414.1380(b)(1) to assign 1-10 points to each measure based on how a MIPS eligible clinician's performance compares to benchmarks. Measures must have the required case minimum to be scored. If a MIPS eligible clinician fails to submit a measure required under the quality performance category criteria, then the MIPS eligible clinician would receive zero points for that measure. MIPS eligible clinicians would not receive zero points if the required measure is submitted (meeting the data completeness criteria as defined in section II.E.5.b.3.b.) but is unable to be scored for any of the reasons listed in this section II.E.6.a.2., such as not meeting the required case minimum or a measure lacks a benchmark). For example, if a MIPS eligible clinician reports a measure that meets the requirements specified in section II.E.5.b., but that measure does not meet the required case minimum criteria or lacks a benchmark, then the measure would not be scored under the MIPS quality performance category, whereas a MIPS eligible clinician that did not report this measure would have the measure scored as a zero. We describe in section II.E.6a.2.d. examples of how points would be allocated and how to compute the overall quality performance category score under these scenarios. Bonus points would be available for reporting high priority measures, defined as outcome, appropriate use, efficiency, care coordination, patient safety, and patient experience measures.

As discussed in section II.E.6.a.2.g., the quality performance category score would be the sum of all the points assigned for the scored measures required for the quality performance category plus the bonus points (subject to the cap) divided by the sum of total possible points. Since MIPS eligible clinicians would be generally required to submit six measures or six measures from a specialty measure set and we would also score MIPS eligible clinicians on up to three population-based measures calculated from administrative claims data as discussed in section II.5.b.6, the total possible points for the quality performance category would be 90 points (6 submitted measures × 10 points + 3 population-based measures × 10 points = 90). However, for eligible groups reporting via CMS Web Interface, the total possible points for the quality performance category would be 210 points (17 measures × 10 points + 3 population-based measures × 10 points = 200), subject to CMS Web Interface reporting criteria. Further, the total possible points for small groups of less than 10 would be 80 points (6 submitted measures × 10 points + 2 population-based measures × 10 points = 80) because under our proposals the all-cause hospital readmissions measure Start Printed Page 28251would not be applicable to groups of less than 10 MIPS eligible clinicians and MIPS eligible clinicians reporting as individuals due to reliability concerns. Therefore, small groups of less than 10 and MIPS eligible clinicians reporting as individuals would only be scored on two population-based measures.

In section II.E.6.b, we discuss how we would score MIPS eligible clinicians who do not have any scored measures in the quality performance category. The details of the proposed scoring methodology for the quality performance category are described below.

(a) Quality Measure Benchmarks

For the quality performance category, we propose at § 414.1380(b)(1) that the performance standard is measure-specific benchmarks. Benchmarks would be determined based on performance on measures in the baseline period. For quality performance category measures for which there are baseline period data, we would calculate an array of measure benchmarks based on performance during the baseline period, breaking baseline period measure performance into deciles. Then, a MIPS eligible clinician's actual measure performance during the performance period would be evaluated to determine the number of points that should be assigned based on where the actual measure performance falls within these baseline period benchmarks. If a measure does not have baseline period information, (for example, new measures) or if the measure specifications for the baseline period differ substantially from the performance period (for example, when the measure requirements change due to updated clinical guidelines), then we would determine the array of benchmarks based on performance on the measure in the performance period, breaking the actual performance on the measure into deciles. In addition, we propose to create separate benchmarks for submission mechanisms that do not have comparable measure specifications. For example, several electronic clinical quality measures have specifications that are different than the corresponding measure from registries. We propose to develop separate benchmarks for EHR submission options, claims submission options, Qualified Clinical Data Registries (QCDRs) and qualified registries submission options.

For CMS Web Interface reporting, we propose to use the benchmarks from the Shared Savings Program as described at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​sharedsavingsprogram/​Quality-Measures-Standards.html. We would adopt the Shared Savings Program performance year benchmarks for measures that are reported through the CMS Web Interface for the MIPS performance period, but would apply the MIPS method of assigning 1 to 10 points to each measure. For example, for the 2017 MIPS performance year, we would use the benchmarks for the 2017 Shared Savings Program performance year, as both the MIPS performance period and the Shared Savings Program performance year use a calendar year for CMS Web Interface reporting. Because the Shared Savings Program does not create benchmarks below the 30th percentile, we would assign all scores below the 30th percentile a value of 2 points, which is consistent with the mid-cluster approach we are proposing for topped out measures. We believe using the same benchmarks for MIPS and the Shared Savings Program for the CMS Web Interface measures would be appropriate because, as is discussed in II.E.5.h., we propose to use the MIPS benchmarks to score the Shared Savings Program and the Next Generation ACO Model on the quality performance category and believe it is important to not have conflicting benchmarks. We would post the MIPS CMS Web Interface benchmarks with the other MIPS benchmarks.

As an alternative approach, we considered creating CMS Web Interface specific benchmarks for MIPS. This alternative would be restricted to CMS Web Interface reporters and would not include other MIPS data submission methods, which are currently used to create the Shared Saving Program benchmarks. This alternative would also apply the topped out cluster approach if any measures are topped out. While we see benefit in having CMS Web Interface methodology match the other MIPS benchmarks, we are also concerned about the Shared Saving Program and the Next Generation ACO Model participants having conflicting benchmark data. We request comments on building CMS Web Interface specific benchmarks.

All MIPS eligible clinicians, regardless of whether they report as an individual or group, and regardless of specialty, that submit data using the same submission mechanism would be included in the same benchmark. We propose to unify the calculation of the benchmark by using the same approach as the VM of weighting the performance rate of each MIPS eligible clinician and group submitting data on the quality measure by the number of beneficiaries used to calculate the performance rate so that group performance is weighted appropriately (77 FR 69321-69322). We would also include APM Entity submissions in the benchmark but would not score APM Entities using this methodology. For APM scoring, we refer to section II.E.5.h.

To ensure that we have robust benchmarks, we propose that each benchmark must have a minimum of 20 MIPS eligible clinicians who reported the measure meeting the data completeness requirement defined in section II.E.5.b.3, as well as meeting the required case minimum criteria for scoring that is defined later in this section. We selected a minimum of 20 because, as discussed below, our benchmarking methodology relies on assigning points based on decile distributions with decimals. A decile distribution requires at least 10 observations. We doubled the requirement to 20 so that we would be able to assign decimal point values and minimize cliffs between deciles. We did not want to increase the benchmark sample size requirement due to concerns that an increase could limit the number of measures with benchmarks.

We also propose that MIPS eligible clinicians who report measures with a performance rate of 0 percent would not be included in the benchmarks. In our initial analysis, we identified some measures that had a large cluster of eligible clinicians with a 0 percent performance rate. We are concerned that the 0 percent performance rate represents clinicians who are not actively engaging in that measurement activity. For example, it could be clinicians reporting the measures that are programmed into their EHR and that are submitted unintentionally, rather than measures the eligible clinician has actively selected for quality improvement. We do not want to inappropriately skew the distribution. We seek comment on whether or not to include 0 percent performance in the benchmark.

We propose at § 414.1380(b)(1)(i) to base the benchmarks on performance in the baseline period when possible, and to publish the numerical benchmarks when possible, prior to the start of the performance period. In those cases where we do not have comparable data from the baseline period, we propose to use information from the performance period to establish benchmarks. While the benchmark methodology would be established in a final rule in advance of the performance period, the actual numerical benchmarks would not be published until after the performance period for quality measures that do not Start Printed Page 28252have comparable data from the baseline period. The methodology for creating the benchmarks is discussed below in this section.

We considered not scoring measures that either are new to the MIPS program or do not have a historical benchmark based on performance in the baseline period. This policy would be consistent with the VM policy in which we do not score measures that have no benchmark (77 FR 69322). However, we are concerned that such a policy could stifle reporting on innovative new measures because it would take several years for the measure to be incorporated into the performance category score. We also believe that any issues related to reporting a new measure would not disproportionately affect the relative performance between MIPS eligible clinicians.

We also considered a variation on the scoring methodology that would provide a floor for a new MIPS measure. Under this variation, if a MIPS eligible clinician reports a new measure under the quality performance category, the MIPS eligible clinician would not score lower than 3 points for that measure. This would encourage reporting on new measures, but also prevent MIPS eligible clinicians from receiving the lowest scores for a new measure, while still measuring variable performance. Finally, we also considered lowering the weight of a new measure, so that new measures would contribute relatively less to the score compared to other measures. In the end, we are not proposing these alternatives we considered, because we want to encourage adoption and measured performance of new measures, however, we do request comment on these alternatives, including comments on what the lowest score should be for MIPS eligible clinicians who report a new measure under the quality performance category and protections against potential gaming related to reporting of new measures only. We also seek comments on alternative methodologies for scoring new measures under the quality performance category, which would assure equity in scoring between the methodology for measures for which there is baseline period data and for new measures which do not have baseline period data available.

Finally, we want to clarify that some PQRS reporting mechanisms have limited experience with all-payer data. For example, under PQRS, all-payer data was permitted only when reporting via registries for measure groups; reporting via registries for individual measures was restricted to Medicare only. Under MIPS however, we intend to have more robust data submissions, as described in section II.E.5.b.3. We recognize that comparing all-payer performance to a benchmark that is built, in part, on Medicare data is a limitation and would monitor the benchmarks to see if we need to develop separate benchmarks. This data issue would resolve in a year or two, as new MIPS data becomes the historical benchmark data in future years.

(b) Assigning Points Based on Achievement

We propose at § 414.1380(b)(1)(x) to establish benchmarks using a percentile distribution, separated by decile categories, because it translates measure-specific score distributions into a uniform distribution of MIPS eligible clinicians based on actual performance values. For each set of benchmarks, we propose to calculate the decile breaks for measure performance and assign points for a measure based on which benchmark decile range the MIPS eligible clinician's performance rate on the measure falls between. For example, MIPS eligible clinicians in the top decile would receive 10 points for the measure, and MIPS eligible clinicians in the next lower decile would receive points ranging from 9 to 9.9. We propose to assign partial points to prevent performance cliffs for MIPS eligible clinicians near the decile breaks. The partial points would be assigned based on the percentile distribution.

Table 17 illustrates an example of using decile points along with partial points to assign achievement points for a sample quality measure. The methodology in this example could apply to measures where the benchmark is based on the baseline period or for new measures where the benchmark is based on the performance period.

In the example above, a MIPS eligible clinician with a measure performance rate of 41 percent would receive 6.0 points based on the benchmark. MIPS eligible clinicians with measure performance rates of 85 percent or above would receive 10 points because they were in the top benchmark decile. We believe that MIPS eligible clinicians within the top decile in performance would warrant receiving the maximum number of points. This is a similar concept to the HVBP “benchmark” level. We note that 85 percent is solely illustrative. Any MIPS eligible clinician who reports some level of performance would receive a minimum of one point for reporting if the measure has the required case minimum, assuming the measure has a benchmark.

In Table 17 we described our scoring approach, using deciles. We do not propose to base scoring on decile distributions for the same measure Start Printed Page 28253ranges as described in Table 17 when performance is clustered at the high end (that is, “topped out” measures), as true variance cannot be assessed. MIPS eligible clinicians report on different measures and often elect to submit measures on which they expect to perform well. With MIPS eligible clinicians electing to report on measures where they expect to perform well, we anticipate many measures would have performance distributions clustered near the top. We propose to identify “topped out” measures by using a definition similar to the definition used in the HVBP: Truncated Coefficient of Variation [13]
is less than 0.10 and the 75th and 90th percentiles are within 2 standard errors; [14]
or median value for a process measure that is 95 percent or greater (80 FR 49550).[15]

Using 2014 PQRS quality reported data measures, we modeled the proposed benchmark methodology and identified that approximately half of the measures proposed under the quality performance category are topped out. Several measures have a median score of 100 percent, which makes it difficult to assess relative performance needed for the quality performance category score.

However, we do not believe it would be appropriate to remove topped out measures at this time. As not all MIPS eligible clinicians would be required to report these measures under our proposals for the quality performance category in section II.E.5.b. it would be difficult to determine whether a measure is truly topped out or if only excellent performers are choosing to report the measure. We also believe removing such a large volume of measures would make it difficult for some specialties to have enough applicable measures to report. At the same time, we do not believe that the highest values on topped out measures convey the same meaning of relative quality performance as the highest values for measures that are not topped out. In other words, we do not believe that eligible clinicians electing to report topped out process measures should be able to receive the same maximum score as eligible clinicians electing to report preferred measures, such as outcome measures.

Therefore, we propose to modify the benchmark methodology for topped out measures. Rather than assigning up to 10 points per measure, we propose to limit the maximum number of points a topped out measure can achieve based on how clustered the scores are. We propose to identify clusters within topped out measures and would assign all MIPS eligible clinicians within the cluster the same value, which would be the number of points available at the midpoint of the cluster. That is, we would take the midpoint of the highest and lowest scores that would pertain if the measure was not topped out and the values were not clustered. We would only apply this methodology for benchmarks based on the baseline period. When we develop the benchmarks, we would identify the clusters and state the points that would be assigned when the measure performance rate is in a cluster. We would notify MIPS eligible clinicians when those benchmarks are published with regard to which measures are topped out.

Table 18 illustrates this hypothetical example. In developing the benchmark, we identified that the top five deciles (50 percent of eligible clinicians reporting the measure) of MIPS eligible clinicians are clustered at 100 percent. We would identify the middle of that cluster (in this example, the top 25 percent or the middle of the eighth decile) and then assign all MIPS eligible clinicians with performance rates in the cluster the same number of points for the measure. The decile points for the hypothetical topped out measure in Table 18 shows that the maximum a MIPS eligible clinician can receive for the topped out measure is 8.5 points in this example.

We propose this approach because we want to encourage MIPS eligible clinicians not to report topped out measures, but to instead choose other measures that are more meaningful. We also seek feedback on alternative ways and an alternative scoring methodology to address topped out measures so that topped out measures do not disproportionately affect a MIPS eligible clinician's quality performance category score. Other alternatives could include placing a limit on the number of topped out measures MIPS eligible clinicians may submit or reducing the weight of topped out measures. We also considered whether we should apply a flat percentage in building the benchmarks, similar to the Shared Savings Program, where MIPS eligible clinicians are scored on their percentage of their performance rate and not on a decile distribution and request comment on how to apply such a methodology without providing an incentive to report topped out measures. Under the Shared Savings Program, 42 CFR 425.502, there are circumstances when benchmarks are set using flat percentages. For some measures, benchmarks are set using flat percentages when the 60th percentile was equal to or greater than 80.00 percent, effective beginning with the 2014 reporting year (78 FR 74759-74763). For other measures benchmarks are set using flat percentages when the 90th percentile was equal to or greater than 95.00 percent, effective beginning in 2015 (79 FR 67925). Flat percentages Start Printed Page 28254allow those with high scores to earn maximum or near maximum quality points while allowing room for improvement and rewarding that improvement in subsequent years. Use of flat percentages also helps ensure those with high performance on a measure are not penalized as low performers. We also note that we anticipate removing topped out measures over time, as we work to develop new quality measures that will eventually replace these topped out measures. We request feedback on these proposals.

(c) Case Minimum Requirements and Measure Reliability and Validity

We seek to ensure that MIPS eligible clinicians are measured reliably; therefore, we propose at § 414.1380(b)(1)(v) to use for the quality performance category measures the case minimum requirements for the quality measures used in the 2018 VM (see § 414.1265): 20 cases for all quality measures, with the exception of the all-cause hospital readmissions measure, which has a minimum of 200 cases. We refer readers to Table 46 of the CY 2016 PFS final rule (80 FR 71282) which summarized our analysis of the reliability of certain claims-based measures used for the 2016 VM payment adjustment. MIPS eligible clinicians that report measures with fewer than 20 cases (and the measure meets the data completeness criteria) would receive recognition for submitting the measure, but the measure would not be included for MIPS quality performance category scoring. Since the all-cause hospital readmissions measure does not meet the threshold for what we consider to be moderate reliability for solo practitioners and groups of less than ten MIPS eligible clinicians for purposes of the VM (see Table 46 of the CY 2016 PFS final rule, referenced above), for consistency, we propose to not include the all-cause hospital readmissions measure in the calculation of the quality performance category for MIPS eligible clinicians who individually report, as well as solo practitioners or groups of two to nine MIPS eligible clinicians.

We also propose that if we identify issues or circumstances that would impact the reliability or validity of a measure score, we would also exclude those measures from scoring. For example, if we discover that there was an unforeseen data collection issue that would affect the integrity of the measure information, we would not want to include that measure in the quality performance category score. If a measure is excluded, we would recognize that the measure had been submitted and would not disadvantage the MIPS eligible clinicians by assigning them zero points for a non-reported measure. In this instance, if the MIPS eligible clinician, as a solo practitioner, scored 10 out of 10 on each of the remaining five measures submitted, and the two population-based measures applicable to solo practitioners, the MIPS eligible clinician would receive a perfect score in the quality performance category (5 measures × 10 points) + (2 population-based measures × 10 points) or 70 out of 70 possible points.

Section II.E.5.b. of this proposed rule outlines our proposed quality performance category criteria for the different reporting mechanisms. The criteria vary by reporting mechanism, but generally we propose to include a minimum of six measures with at least one cross-cutting measure (for patient facing MIPS eligible clinicians) (Table C) and an outcome measure if available. If an outcome measure is not available, then the eligible clinician would report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. MIPS eligible clinicians and groups would have to select their measures from either the list of all MIPS Measures in Table A or a set of specialty specific measures in Table E.

We note that there are some special scenarios for those MIPS eligible clinicians who select their measures from the Specialty Sets (Table E) as discussed in section II.E.5.b.

For groups using the CMS Web Interface and MIPS APMs, we propose to have different quality performance category criteria described in sections II.E.5.b. and II.E.5.h. Additionally, as described in section II.E.5.b. we also propose to score MIPS eligible clinicians on up to three population-based measures.

Previously in PQRS, EPs had to meet all the criteria or be subject to a negative payment adjustment. We heard from numerous commenters a desire to move away from “all-or-nothing” scoring. Therefore, in MIPS, we propose that MIPS eligible clinicians receive credit for measures that they report, regardless of whether or not the MIPS eligible clinician meets the quality performance category submission criteria. Section 1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring methodology, MIPS eligible clinicians who fail to report on an applicable measure or activity that is required to be reported shall be treated as receiving the lowest possible score for the measure or activity; therefore, for any MIPS eligible clinician who does not report a measure required to satisfy the quality performance category submission criteria, we propose that the MIPS eligible clinician would receive zero points for that measure. For example, a MIPS eligible clinician who is able to report on six measures, yet reports on four measures, would receive two “zero” scores for the missing measures. In another example, a patient facing MIPS eligible clinician reports more than six measures, but does not elect to report a cross-cutting measure and an outcome measure, or if one is not available, another high priority measure. The MIPS eligible clinician in that scenario would receive at least two “zero” scores for not reporting measures required by the quality performance category criteria.

However, MIPS eligible clinicians who report a measure that does not meet the required case minimum would not be scored on the measure but would also not receive a “zero” score. For example, a MIPS eligible clinician who submits six measures as part of a group with 10 or more clinicians, one of which does not meet the required case minimum, would be scored on the five remaining measures and the three population-based measures based on administrative claims data. If the MIPS eligible clinician scored 10 out of 10 on each of these measures, the MIPS eligible clinician would receive a perfect score in the quality performance category (5 measures × 10 points) + (3 population-based measures × 10 points) or 80 out of 80 possible points.

We also note that if MIPS eligible clinicians are able to submit measures that can be scored, we want to discourage them from continuing to submit the same measures year-after-year that cannot be scored due to not meeting the required case minimum. Rather, to the fullest extent possible, MIPS eligible clinicians should select measures that would have a required case minimum. We seek comment on any safeguards we should implement in future years to minimize any gaming attempts. For example, if the measures that a MIPS eligible clinician submits for a performance period are not able to be scored due to not meeting the required case minimum, we seek comment on whether we should require these MIPS eligible clinicians to submit different measures with sufficient cases for the next performance period (to the Start Printed Page 28255extent other measures are applicable and available to them).

MIPS eligible clinicians who report a measure where there is no benchmark due to less than 20 MIPS eligible clinicians reporting on the measure would not be scored on the measure but would also not receive a “zero” score. Instead, these MIPS eligible clinicians would be scored according to the following example: A MIPS eligible clinician who submits six measures through a group of 10 or more clinicians, with one measure lacking a benchmark, would be scored on the five remaining measures and the three population-based measures based on administrative claims data. If the MIPS eligible clinician scored 10 out of 10 on each of these measures, the MIPS eligible clinician would receive a perfect score in the quality performance category (5 measures × 10 points) + (3 population-based measures × 10 points) or 80 out of 80 possible points.

We intend to develop a validation process to review and validate a MIPS eligible clinician's inability to report on the quality performance requirements as proposed in section II.E.5.b. We anticipate that this process would function similar to the Measure Applicability Validity (MAV) process that occurred under PQRS, with a few exceptions. First, the MAV process under PQRS was a secondary process after an EP was determined to not be a satisfactory reporter. Under MIPS, we intend to build the process into our overall scoring approach to reduce confusion and burden on MIPS eligible clinicians by having a separate process. Second, as the requirements under PQRS are different than those proposed under MIPS, the process must be updated to account for different measures and different quality performance requirements. More information on the MAV process under PQRS can be found at http://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​PQRS/​Downloads/​2016_​PQRS_​MAV_​ProcessforClaimsBasedReporting_​030416.pdf. We request comments on these proposals.

(e) Incentives To Report High Priority Measures

Consistent with other CMS value-based payment programs, we propose that MIPS scoring policies would emphasize and focus on high priority measures that impact beneficiaries. These high priority measures are defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures; see Tables A-D for these measures. We propose these measures as high priority measures given their critical importance to our goals of meaningful measurement and our measure development plan. We note that many of these measures are grounded in NQS domains. For patient safety, efficiency, patient experience and care coordination measures, we refer to the measures within the respective NQS domains and measure types. For outcomes measures, we include both outcomes measures and intermediate outcomes measures. For appropriate use measures, we have noted which measures fall within this category in Tables A-D and provided criteria for how we identified these measures in section II.E.5.b. For non-MIPS measures reported through QCDRs, we propose to classify which measures are high priority during the measure review process.

We are proposing scoring adjustments to create incentives for MIPS eligible clinicians to submit certain high priority measures and to allow these measures to have more impact on the total quality performance category score.

We propose to create an incentive for MIPS eligible clinicians to voluntarily report additional high priority measures. We propose to provide two bonus points for each outcome and patient experience measure and one bonus point for other high priority measures reported in addition to the one high priority measure (an outcome measure, but if one is not available, then another high priority measure) that would already be required under the proposed quality performance category criteria. For example, if a MIPS eligible clinician submitted two outcome measures, and two patient safety measures, the MIPS eligible clinician would receive two bonus points for the second outcome measure reported and two bonus points for the two patient safety measures. The MIPS eligible clinician would not receive any bonus points for the first outcome measure submitted since that is a required measure. We selected two bonus points for outcome measures given the statutory requirements under section 1848(q)(2)(C)(i) of the Act to emphasize outcome measures. We selected two bonus points for patient experience measures given the importance of patient experience measures to our measurement goals. We selected one bonus point for all other high priority measures given our measurement goals around each of those areas of measurement. We believe the number of bonus points provides extra credit for submitting the measure, yet would not mask poor performance on the measure. For example, a MIPS eligible clinician with poor outcomes receives only two points for performance for a particular high priority measure. The bonus points would increase the MIPS eligible clinician's points to three (or four if the measure is an outcome measure or patient experience measure), but that amount is far less than the ten points a top performer would receive. We note that population-based measures would not receive bonus points.

We note that a MIPS eligible clinician who submits a high priority measure but had a performance rate of 0 percent would not receive any bonus points. Eligible clinicians would only receive bonus points if the performance rate is greater than zero. Bonus points are also available for measures that are not scored (not included in the top 6 measures for the quality performance category score) as long as the measure has the required case minimum and data completeness. We believe these qualities would allow us to include the measure in future benchmark development.

For groups submitting data through the CMS Web Interface, including MIPS APMs that report through the CMS Web Interface, groups are required to submit a set of predetermined measures and groups are unable to submit additional measures. For that submission mechanism, we propose to apply bonus points based on the finalized set of measures. We would assign two bonus points for each outcome measure (after the first required outcome measure) and for each patient experience measure. We would also have one additional bonus point for each other high priority measure (patient safety, efficiency, appropriate use, care coordination). We believe MIPS eligible clinicians or groups should have the ability to receive bonus points for reporting high priority measures through all submission mechanisms, including the CMS Web Interface. In the final rule, we will publish how many bonus points the CMS Web Interface measure set would have available based on the final list of measures.

We propose to cap the bonus points for the high priority measures (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures) at 5 percent of the denominator of the quality performance category score. Tables 19 and 20 illustrate examples of how to calculate the bonus cap. We also propose an alternative approach of capping bonus points for high priority measures at 10 percent of the denominator of the quality performance category score. Our rationale for the 5 Start Printed Page 28256percent cap is that we do not want to mask poor performance by allowing an MIPS eligible clinician to perform poorly on a measure but still obtain a high quality performance category score by submitting numerous high priority measures in order to obtain bonus points; however, we are also concerned that 5 percent may not be enough incentive to encourage reporting. We request comment on the appropriate threshold for this bonus cap.

(f) Incentives To Use CEHRT To Support Quality Performance Category Submissions

Section 1848(q)(5)(B)(ii) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall: (I) Encourage MIPS eligible clinicians to report on applicable measures under the quality performance category through the use of CEHRT and QCDRs; and (II) with respect to a performance period for a year, for which a MIPS eligible clinician reports applicable measures under the quality performance category through the use of CEHRT, treat the MIPS eligible clinician as satisfying the clinical quality measures reporting requirement under section 1848(o)(2)(A)(iii) of the Act for such year. To encourage the use of CEHRT for quality improvement and reporting on measures under the quality performance category, we are proposing a scoring incentive to MIPS eligible clinicians who use their CEHRT systems to capture and report quality information.

We propose to allow one bonus point under the quality performance category score, up to a maximum of 5 percent of the denominator of the quality performance category score if:

The MIPS eligible clinician uses CEHRT to record the measure's demographic and clinical data elements in conformance to the standards relevant for the measure and submission pathway, including but not necessarily limited to the standards included in the CEHRT definition proposed in 414.1305;

The MIPS eligible clinician exports and transmits measure data electronically to a third party using relevant standards or directly to CMS using a submission method as defined at § 414.1325; and

The third party intermediary (for example, a QCDR) uses automated software to aggregate measure data, calculate measures, perform any filtering of measurement data, and submit the data electronically to CMS using a submission method as defined at § 414.1325.

These requirements are referred to as “end-to-end electronic reporting.”

We note that this bonus would be in addition to the high priority bonus. MIPS eligible clinicians would be eligible for both this bonus option and the high priority bonus option with separate bonus caps for each option. We also propose an alternative approach of capping bonus points for this option at 10 percent of the denominator of the quality performance category score. Our rationale for the 5 percent cap is that we do not want to mask poor performance by allowing a MIPS eligible clinician to perform poorly on a measure but still obtain a high quality performance category score by submitting numerous measures in order to obtain bonus points; however, we are also concerned that 5 percent may not be enough incentive to encourage end-to-end electronic reporting. We seek comment on the appropriate threshold for this bonus cap. We propose the CEHRT bonus would be available to all submission mechanisms except claims submissions. This incentive would also be available for MIPS APMs reporting through the CMS Web Interface. Specifically, MIPS eligible clinicians who report via qualified registries, QCDRs, EHR submission mechanisms, and CMS Web Interface may receive one bonus point for each reported measure with a cap as described. We do not propose to allow this option for claims submission, because there is no mechanism for MIPS eligible clinicians to identify the information was pulled using an EHR.

This approach supports and encourages innovative approaches to measurement using the full array of standards ONC adopts, and the data elements MIPS eligible clinicians capture and exchange, to support patient care. Thus, approaches where a qualified registry or QCDR obtains data from a MIPS eligible clinician's CEHRT using any of the wide range of ONC-adopted standards and then uses automated electronic systems to perform aggregation, calculation, filtering, and reporting would qualify each such measure for the CEHRT bonus point. In addition, measures submitted using the EHR submission mechanism or the EHR submission mechanism through a third party would also qualify for the CEHRT bonus.

We request comment on this proposed approach.

(g) Calculating the Quality Performance Category Score

The next two subsections provide a detailed description of how the quality performance category score would be calculated under our proposals.

To calculate the quality performance category score, we propose at § 414.1380(b)(1)(xv) to sum the weighted points assigned for the measures required by the quality performance category criteria plus the bonus points and divide by the weighted sum of total possible points.

If a MIPS eligible clinician elects to report more than the minimum number of measures to meet the MIPS quality performance category criteria, then we would only include the scores for the measures with the highest number of assigned points. For example, if a patient facing MIPS eligible clinician's quality submission criteria is to report six measures with at least one cross-cutting measure and a high priority measure, and the MIPS eligible clinician reports eight process measures (three using CEHRT), one cross-cutting measure, and one outcome measure, then we propose to use the four process measures with the highest number of assigned points, plus the cross-cutting measure and the outcome measure, in addition to the two population-based measures (the all-cause readmission measure would not apply to an MIPS eligible clinician reporting individually), to calculate the quality performance category score. Allowing MIPS eligible clinicians to report additional measures without including them in the scoring allows MIPS eligible clinicians to become familiar with new measures and gain experience with those measures. It also provides the foundation for the MIPS eligible clinician to receive credit for improvement on those measures in future years.

If a MIPS eligible clinician has met the quality performance category submission criteria for reporting quality information, but does not have any scored measures as discussed in section II.E.6.b.2., then a quality performance category score would not be calculated. Refer to section II.E.6.a.2.d. for details on how we propose to address scenarios where a quality performance category score is not calculated for a MIPS eligible clinician.

The following example illustrates a sample scoring methodology. In this scenario, a MIPS eligible clinician submits individually via registry three process measures, one outcome measure, and one other high priority measure. Two of the process measures and one outcome measure qualify for Start Printed Page 28257the CEHRT bonus. The patient facing MIPS eligible clinician did not submit on an expected cross-cutting measure and therefore would receive zero points for that requirement. Measures that do not meet the required case minimum or do not have a benchmark are not used for scoring. We reiterate that a measure that is not scored due to not meeting the required case minimum or lack of a measure benchmark would be treated differently than a required measure that is not reported. Any required measure that is not reported, or reported in a way that does not meet the data completeness requirements, would receive a score of zero points and be considered a scored measure. Table 19 illustrates the example.

The total possible points for the eligible clinician is 70 points. The eligible clinician has 48.2 points based on performance. The eligible clinician also qualifies for one bonus point for reporting an additional high priority patient safety measure and three bonus points for end-to-end electronic reporting of quality measures. The bonus points for high priority measures and CEHRT reporting are both under two separate caps which is 5 percent of 70 possible points or 3.5 points per bonus category). The quality performance category score for this MIPS eligible clinician is (48.2 points + 4 bonus points = 52.2)/70 total possible points = 74.6 percent. The quality performance category score would be capped at 100 percent.

The following example in Table 20 illustrates how to calculate the bonus cap for the high priority measure bonus and the CEHRT bonus. In the scenario below, the MIPS eligible clinician has submitted six measures and would also be scored on two of the three population-based measures. The MIPS eligible clinician below successfully submitted five quality measures using end-to-end electronic reporting, and therefore, qualifies for the CEHRT bonus of one point for each of those measures. In addition to CEHRT bonus points, the MIPS eligible clinician reported outcome measures for high priority bonus points. The MIPS eligible clinician reported two outcome measures and receives two bonus points for the second outcome measure, given that no bonus points are given for the first required measure. However, both bonus categories are over the cap (which is 5 percent of 80 possible points or four points per bonus category). The quality performance category score for this MIPS eligible clinician is 68.8 (60.8 + 4 CEHRT bonus points after the cap + 4 Start Printed Page 28258high priority bonus points after the cap) or 86 percent (68.8/80). Note, in section II.E.5.b.(2), we propose to weight the quality performance category at 50 percent of the MIPS CPS, so an 86 percent quality performance category score would account for 50 percent of the CPS.

We request comment on our proposals to calculate the quality performance category score.

CMS Web Interface reporters have different quality performance category submission criteria; therefore, we propose to modify our scoring logic slightly to accommodate this submission mechanism. CMS Web Interface users report on the entire set of measures specified for that mechanism. Therefore, rather than scoring the top six reported measures, we propose to score all measures. If a group does not meet the reporting requirements for one of the measures, then the group would receive zero points for that measure. We note that since groups reporting through the Web Interface are required to report on all measures, and since some of those measures are “high priority,” these groups would always have some bonus points for the quality performance category score if all the measures are reported. That is, the group would either report on less than all web interface measures, in which case the group would receive zeros for unreported measures, or the group would report on all measures, in which case the group would automatically be eligible for bonus points. The other proposals for scoring discussed in section II.E.6.a.2.g.i., including bonus points, would still apply for CMS Web Interface. We request comment on this proposal.

(h) Measuring Improvement

Section 1848(q)(3)(B) of the Act requires the Secretary, in establishing performance standards for measures and activities for the MIPS performance categories, to consider: Historical performance standards; improvement; and the opportunity for continued improvement. In addition, under section 1848(q)(5)(D) of the Act, beginning with the second year of the MIPS, if data sufficient to measure improvement are available, the CPS methodology shall take into account improvement of the MIPS eligible clinician in calculating the performance score for the quality and resource use performance categories and may take into account improvement for the CPIA and advancing care information performance categories.

We are soliciting public comments on potential ways to incorporate improvement into the scoring methodology moving forward. We are especially interested in feedback on the following three options, with the assumption that eligible clinicians would report the same measures year-to-year (where possible). We are also interested in feedback on how to score improvement given that a MIPS eligible clinician can change measures and submission mechanisms from year-to-year. In addition, a MIPS eligible clinician can elect to report as an individual or a member of a group and that election can vary from year to year. Finally, we seek feedback on whether to score improvement where MIPS eligible clinicians do not have the required case minimum for measures to be scored.

Option 1: We could adopt the approach for assessing improvement currently used for the HVBP, where we assign from 1-10 points for achievement and from 1-9 points for improvement for each measure. We would compare the achievement and improvement points for each measure in the quality performance category and score whichever is greater. Specifically, we would determine two scores for a MIPS eligible clinician at the measure level for the quality performance category. First, we would assess the MIPS eligible clinician's achievement score, which measures how the MIPS eligible clinician performed compared to benchmark performance scores for each applicable measure in the quality performance category. Second, we would assess the MIPS eligible clinician's improvement score, which measures how much a MIPS eligible clinician has improved compared to the MIPS eligible clinician's own previous performance during a baseline period for each applicable measure in the quality performance category. Under this methodology, we would compare the achievement and improvement scores for each measure and only use whichever is greater, but only those eligible clinicians with the top Start Printed Page 28259achievement would be able to receive the maximum number of points. If a MIPS eligible clinician's practice was not open during the baseline period but was open during the performance period, points would be awarded based on achievement only for that performance period. For a more detailed description of the HVBP methodology, we refer readers to § 412.160 and § 412.165.

Option 2: We could adopt the approach for assessing improvement currently used in the Shared Savings Program, where eligible clinicians or groups would receive a certain number of bonus points for the quality performance category for improvement, although the total points received for the performance may not exceed the maximum total points for the performance category in the absence of the quality improvement points. Under this methodology, we would score individual measures and determine the corresponding number of points that may be earned based on the MIPS eligible clinician's performance. We would add the points earned for the individual measures within the quality performance category and divide by the total points available for the performance category to determine the quality performance category score. MIPS eligible clinicians that demonstrate quality improvement on established quality measures from year-to-year would be eligible for up to four bonus points for the quality performance category. Bonus points would be awarded based on a MIPS eligible clinician's net improvement in measures within the quality performance category, which would be calculated by determining the total number of significantly improved measures and subtracting the total number of significantly declined measures. Up to four bonus points would be awarded based on a comparison of the MIPS eligible clinician's net improvement in performance on the measures to the total number of individual measures in the quality performance category. When bonus points are added to points earned for the quality measures in the quality performance category, the total points received for the quality performance category may not exceed the maximum total points for the performance category in the absence of the quality improvement points. For a more detailed description of the Shared Savings Program methodology, we refer readers to § 425.502, as well as CY 2015 PFS final rule with comment (79 FR 67928-67931) for a discussion of how CMS will determine whether the improvement or decline is significant.

Option 3: We could adopt the approach similar to that for assessing improvement for the Medicare Advantage 5-star rating methodology. Under this approach, we would identify an overall “improvement measure score” by comparing the underlying numeric data for measures from the prior year with the data from measures for the performance period. To obtain an “improvement measure score” MIPS eligible clinicians would need to have data for both years in at least half of the required measures for the quality performance category. The numerator for the overall “improvement measure” would be the net improvement, which is a sum of the number of significantly improved measures minus the number of significantly declined measures. The denominator is the number of measures eligible for improvement since to qualify for use in the “improvement measure” calculation, a measure must exist in both years and not have had a significant change in its specification. This “improvement measure” would be included in the quality performance category. We recognize that high performing MIPS eligible clinicians may have less room for improvement and consequently may have lower scores on the overall “improvement measure”. Therefore, under this option we would propose the following rule, which is similar to how the 5-star rating methodology treats highly rated plans in connection with the improvement measure to avoid penalizing consistently high-performing eligible clinicians: We would calculate a MIPS eligible clinician's score with the “improvement measure” and without, and use the MIPS eligible clinician's best score. We request comments on these proposals.

(3) Scoring the Resource Use Performance Category

As we described in section II.E.6.a.1. of this rule, we proposed to align scoring across the MIPS performance categories. For the resource use performance category, we propose to score the resource use measures similarly to the quality performance category. Specifically, we propose at § 414.1380(b)(2) to assign one to ten points to each measure based on a MIPS eligible clinician's performance compared to a benchmark. However, we note that for the resource use performance category (unlike the quality performance category), the benchmark is based on the performance period, rather than the baseline period. The details of the scoring for resource use measures are described below.

(a) Resource Use Measure Benchmarks

For the resource use performance category, we propose at § 414.1380(b)(2) that the performance standard is measure-specific benchmarks. We would calculate an array of measure benchmarks based on performance. Then, a MIPS eligible clinician's actual measure performance during the performance period would be evaluated to determine the number of points that should be assigned based on where the actual measure performance falls within these benchmarks.

We propose at § 414.1380(b)(2) to create benchmarks for the resource use measures based on the performance period. Changes in payment policies, including changes in relative value units, and changes that affect how hospitals, clinicians and other health care providers are paid under Medicare Parts A and B, can make it challenging to compare resource use in a performance period with a historical baseline period. In addition, for HVBP and VM, we use the performance period to establish the benchmarks for scoring HVBP's efficiency measures and VM's cost measures (80 FR 49562, 80 FR 71280). If we use the performance period, we would publish the benchmark methodology in a final rule, but would not be able to publish the actual numerical benchmarks in advance of the performance period. We believe that it is important for MIPS eligible clinicians to know in advance how they might be scored and can track their performance so we would continue to provide performance feedback with information on the MIPS eligible clinician's relative performance.

We considered an alternative to base the resource use performance category measure benchmarks on the baseline period proposed in section II.E.6.a.1.c., rather than the performance period. This option would further align the resource use performance category benchmark methodology with the quality performance category benchmark methodology. This option would also allow us to publish the numerical benchmarks before the performance period ends; however, we believe the benefits of earlier published benchmarks are more limited for resource use measures. MIPS eligible clinicians would not be able to track their daily progress because they would not have all the necessary information to determine the attribution, price standardization, and otherwise adjust the measures. We believe the relative performance that we provide through Start Printed Page 28260feedback reports would provide MIPS eligible clinicians the information they need to track performance and to learn about their resource utilization. In addition, we believe that using benchmarks based in the performance period is a better approach than using benchmarks based in the baseline period because different payment policies could apply during the baseline period than during the performance period which could affect a MIPS' eligible clinician's resource use. We would also have to identify the baseline benchmark and trend it forward so that the dollars in the baseline period are comparable to the performance period, whereas we would not have to make a trending adjustment for benchmarks based on the performance period. For these reasons, we elected to propose to base the benchmarks on the performance period rather than the baseline period.

We propose to create a single set of benchmarks for each measure specified for the resource use performance category. All MIPS eligible clinicians that are attributed sufficient cases for the measure would be included in the same benchmark. In addition, we would require a minimum of 20 MIPS eligible clinicians or groups to be attributed the case minimum in order to develop the benchmark. If a measure does not have enough eligible clinicians or groups that are attributed enough cases to create a benchmark, then we would not include that measure in the scoring for the resource use performance category.

We request comment on the proposal to establish resource use measure benchmarks based on the performance period as well as the alternative proposal.

(b) Assigning Points Based on Achievement

For each set of benchmarks, we propose to calculate the decile breaks based on measure performance during the performance period and assign points for a measure based on which benchmark decile range the MIPS eligible clinician's performance on the measure is between. We propose that for resource use measures, lower costs represent better performance. In other words, MIPS eligible clinicians in the top decile would have the lowest resource use. We propose to use a methodology generally consistent with the methodology proposed for the quality performance category. We refer readers to Tables 21 and 22 for details on assigning points based on decile distribution. We request comments on the methodology for assigning points based on performance period deciles for the resource use performance category and solicit comments on alternative methodologies for assigning points for performance under this performance category for future rulemaking.

Table 21 illustrates an example of using decile points along with partial points to assign achievement points for a sample resource use measure.

(c) Case Minimum Requirements

We seek to ensure that MIPS eligible clinicians are measured reliably; therefore, we proposed in section II.E.5.e.3. to establish a 20 case minimum for each resource use measure. We note that this would include the Medicare Spending Per Beneficiary (MSPB) measure. In the CY 2016 PFS final rule, we finalized a policy that increases the required case minimum for MSPB from 20 to 125 cases (80 FR 71295-71296). However, due to the proposed changes to the MSPB measure, discussed in section II.E.5.e.(3)(a)., we believe we can appropriately use a required case minimum of 20 for the revised MSPB measure. Refer to section II.E.5.e.(3) for our rationale for this proposal.

(d) Calculating the Resource Use Performance Category Score

To calculate the resource use performance category score, we propose at § 414.1380(b)(2)(iii) to average all the scores of all the resource use measures attributed to the MIPS eligible clinician. All measures in the resource use performance category as described in section II.E.5.e would be weighted equally. If a MIPS eligible clinician has only one resource use measure with a required case minimum to be scored, we would score that measure accordingly, and the MIPS eligible clinician's resource use performance category score would consist of the score for that one measure. We note that MIPS eligible clinicians cannot receive a zero score for any resource use measure for failure to submit the measure since none of the resource use performance category measures are submitted by MIPS eligible clinicians. Rather, these measures are attributed to MIPS eligible clinicians through claims data. However, if a MIPS eligible clinician is not attributed any resource use measures (for example, because the case minimum requirements have not been met for any measure or there is not a sufficient number of MIPS eligible clinicians to create a benchmark for any measure), then a resource use performance category score would not be calculated. Refer to section II.E.6.b for details on how we propose to address scenarios where a performance category score is not calculated for a MIPS eligible clinician. MIPS eligible clinicians would receive performance feedback as Start Printed Page 28261required under section 1848(q)(12) of the Act and discussed in section II.E.8.a of this proposed rule. Over time, performance feedback may include a list of attributed cases for each measure by MIPS eligible clinician. We request comment on our proposals to calculate the resource use performance category score.

Table 22 illustrates a sample scoring methodology for a limited set of measures. A MIPS eligible clinician is attributed resource use measures as described above and receives a score for measures where the eligible clinician has a sufficient number of cases attributed.

The MIPS eligible clinician described in Table 22 did not have the required case minimum for Measure 4 (Episode 2), and therefore is not scored on this measure. Similarly, the MIPS eligible clinician was not attributed any cases for Measure 5 (Episode 3) and was not scored on the measure. Measures that do not meet the required case minimum are not used for scoring.

In the example above, making the assumption that all measures listed have a median performance falling between the fifth and sixth deciles and would provide a score of six points, the MIPS eligible clinician with a value above the median would receive a score lower than six points. For example, Measure 1 has a performance of $15,000 which is higher than the median performance of $13,000, therefore the number of points assigned (4.0) is lower than six points.

Based on the resource use measures available for scoring, the MIPS eligible clinician is scored against the total number of points available. The resource use performance category score for this eligible clinician is (22.3 performance points/40 possible points) = 55.8 percent.

Unlike the quality performance category score, we are not proposing bonus points as part of the resource use performance category score.

(4) Scoring the CPIA Performance Category

Section 1848(q)(5)(C) of the Act outlines specific scoring rules for the CPIA performance category. Section 1848(q)(5)(C)(i) of the Act provides that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home or comparable specialty practice with respect to a performance period shall receive the highest potential score for the CPIA performance category for such period. Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible clinicians participating in an APM with respect to a performance period shall earn a minimum score of one-half of the highest potential score for the CPIA performance category for such period. We refer readers to section II.E.5.h of this preamble for a description of the APM scoring standard. Section 1848(q)(5)(C)(iii) of the Act states that MIPS eligible clinicians are not required to perform activities in each subcategory or participate in an APM in order to receive the highest possible score for the CPIA performance category. Based on these criteria, we propose a scoring methodology that assigns points for the CPIA performance category (based on patient-centered medical home participation and the CPIAs reported by the MIPS eligible clinician). A MIPS eligible clinician's performance would be evaluated by comparing the reported CPIAs to the highest possible score.

(a) Assigning Points to Reported CPIAs

CPIA is a new performance category that has not been implemented in our previous programs. Therefore, in year 1, we cannot assess how well the MIPS eligible clinician has performed on the activity against data from a baseline year. We can only assess whether the MIPS eligible clinician has participated sufficiently to receive credit in the CPIA performance category. Therefore, we propose at § 414.1380(b)(3) to assign points for each reported activity within two categories: Medium-weighted and high-weighted activities. Medium-weighted activities are worth 10 points. High-weighted activities are worth 20 points. Table 23 lists all of the proposed CPIAs that are high-weighted. All other activities not listed as high-weighted activities would be considered medium activities. Table H in the Appendices provides the CPIA Inventory of all activities, both medium-weighted and high-weighted. Consistent with our unified scoring system principles, MIPS eligible clinicians would know in advance how many potential points they could receive for each CPIA.

Activities are proposed to be weighted as high based on the extent to which they align with activities that support the patient-centered model home, since that is the standard under section 1848(q)(5)(C)(i) of the Act for achieving the highest potential score for the CPIA performance category, as well as with CMS priorities for transforming clinical practice. Additionally, activities that require performance of multiple actions, such as participation in the Start Printed Page 28262Transforming Clinical Practice Initiative, participation in a MIPS eligible clinician's state Medicaid program, or an activity identified as a public health priority (such as emphasis on anticoagulation management or utilization of prescription drug monitoring programs) are justifiably weighted as high. We seek comment on which activities should receive a high weight as opposed to a medium weight.

We also considered an approach of equal weighting for all CPIAs. We seek comment on a multi-tier weighting approach such as low, medium and high activity categories for future years of MIPS.

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(b) CPIA Performance Category Highest Potential Score

Although there is variability in the level that each MIPS eligible clinician would perform a CPIA, we currently do not have a standard way of measuring that variability. In future years, we plan to capture data to begin to develop a baseline for measuring CPIA improvement. Because we cannot measure variable performance within a CPIA, we propose at § 414.1380(b)(3)(v) to compare the points associated with the reported activities against the highest potential score. We propose the highest potential score to be 60 points for the CY 2017 performance period given the following rationale.

Based on discussions with several high performing organizations, we believe that MIPS eligible clinicians would be able to report on as many as six activities of medium weight. Examples of these organizations include one that led a major redesign of patient workflow after Hurricane Katrina, implementing clinical practice improvements to ensure patients receive faster treatment in the event of future disasters, ranked nationally in 6 adult specialties and high-performing in 6 Start Printed Page 28266adult specialties; [16]
a second that was recognized by a leading medical association that achieved: 6.7 percent 30-day all cause readmissions, 42 percent fewer ED visits with implementation of a 60-day intensive home care program, costs of 15 percent-28 percent below regional average and significant improvement in patient surveys from CAHPS; [17]
and a third recognized as a leader in rural health with the highest award for excellence from the National Rural Primary Care Association.

We also believe that a top performing small practice (consisting of 15 or fewer professionals) or practice in a rural or health professional shortage area, or a non-patient facing MIPS eligible clinician would be able to report on at least two activities. In consideration of special circumstances for these small practices, as well as practices located in rural areas and in Health Professional Shortage Areas (HPSAs) or non-patient facing MIPS eligible clinicians, we propose that the weight for any activity selected would be 30 points. For any MIPS eligible clinician, the maximum total points achievable in this performance category is 60 points. Based on the above rationale, we believe it is reasonable to expect all MIPS eligible clinicians to be able to report CPIAs, and as such, a MIPS eligible clinician reporting no CPIA would receive a zero score for the CPIA performance category. We believe this proposal allows us to capture variation in reporting the CPIA performance category.

Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period must be given the highest potential score for the CPIA performance category for the performance period. We propose that patient-centered medical home practices are those that have received accreditation from any of the following four nationally recognized accreditation organizations (the Accreditation Association for Ambulatory Health Care, the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Commission (URAC)); [18]
or are a Medicaid Medical Home Model or Medical Home Model. We propose that CMS's proposed comparable specialty practices are those that include the NCQA Patient-Centered Specialty Recognition. We refer readers to section II.F. of this proposed rule for further description of the Medicaid Medical Home Model or Medical Home Model. The four accreditation organizations listed above all have evidence of being used by a large number of medical organizations as the model for their patient-centered medical home and are national in scope. No other criteria are required for receiving recognition as a certified patient patient-centered medical home or comparable specialty practice except for being recognized by one of the above organizations.

Section II.E.5.f. of this rule outlines the policy for certified patient-centered medical homes. The organizations identified above maintain a list of certified patient-centered medical homes, including the Medicaid Medical Home and Medical Home Models, that would be used to determine whether a MIPS eligible clinician qualifies for the highest potential score for the CPIA performance category because the MIPS eligible clinician is in a certified patient-centered medical home. NCQA maintains a list of practices that have received the Patient-Centered Specialty Recognition which would be used to determine whether a MIPS eligible clinician qualifies for the highest potential score for the CPIA performance category because the MIPS eligible clinician is in a comparable specialty practice.

We propose at § 414.1380(b)(3) that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home, including a Medicaid Medical Home or Medical Home Model, or comparable specialty practice in accordance with those proposals would receive the highest potential score (in accordance with section 1848(q)(5)(C)(i) of the Act) of 60 points for the CPIA performance category.

(1) Section II.E.5.f. of this rule presents the CMS Study on CPIA and Measurement. Given the burden for participants completing the year-long study and the value of collectively examining innovation and practice activities to improve clinical quality data submissions and further reduce time requirements for eligible clinicians and groups to report, we propose that MIPS eligible clinicians and groups that successfully participate and submit data to fulfill study requirements would receive the highest potential score of 60 points for the CPIA performance category.

(d) Calculating the CPIA Performance Category Score

To determine the CPIA performance category score, we propose to sum the points for all of the MIPS eligible clinician's reported activities and divide by the proposed CPIA performance category highest potential score of 60. A perfect score would be 60 points divided by 60 possible points, which equals 100 percent. If MIPS eligible clinicians have more than 60 CPIA points, then we propose to cap the resulting CPIA performance category score at 100 percent.

Table 24 illustrates a sample scoring methodology for the CPIA performance category. The MIPS eligible clinician below was not an APM participant and does not immediately earn the minimum score of one-half of the highest potential score or 30 points that are available for APM participation. The MIPS eligible clinician below completed two high-weighted activities worth 20 points each and two medium-weighted activities for 10 points each in order to receive the maximum 60 points available in the performance category for a CPIA performance category score of 100 percent.

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Alternatively, the MIPS eligible clinician could have selected three high-weighted activities for 20 points each, six medium-weighted activities for ten points each, or some combination to reach 60 points. The score however is capped at 100 percent (60/60). This means that a MIPS eligible clinician who selects four high-weight activities (80 possible points) would still be given a score of 100 percent (60/60).

Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and in geographic health professional shortage areas (HPSAs) (as designated under section 332(a)(1)(A) of the Public Health Service Act) in defining activities. Section 1848(q)(2)(C)(iv) of the Act also requires the Secretary to give consideration to non-patient-facing MIPS eligible clinicians. Further, section 1848(q)(F)(5) of the Act allows the Secretary to assign different scoring weights for measures, activities, and performance categories, if there are not sufficient measures and activities applicable and available to each type of eligible clinician.

For MIPS eligible clinicians and groups that are small practices (consisting of 15 or fewer professionals), practices located in rural areas, practices located in geographic HPSAs, or non-patient facing MIPS eligible clinicians or non-patient facing MIPS eligible clinician groups, we propose alternative scoring requirements for the CPIA performance category. The rationale for this alternative scoring is grounded in the resource constraints these MIPS eligible clinicians face which was further discovered during listening sessions with small, rural and geographic HPSAs and medical societies for non-patient facing MIPS eligible clinicians and groups. We believe that while non-patient facing MIPS eligible clinicians and non-patient facing groups could select activities from some sub-categories (such as care coordination and patient safety), for other sub-categories (such as beneficiary engagement and population management) non-patient facing MIPS eligible clinicians and groups will need to consider novel practice activities that are within their scope and can improve beneficiary care. We will continue to work with non-patient facing MIPS eligible clinician professional organizations to further develop activities relevant for these clinicians in future years. Our rationale for small practices and practices located in rural areas and in HPSAs is grounded in the resource constraints that these MIPS eligible clinicians face. This rationale is especially compelling given that each activity requires at least 90 days and may not necessarily be conducted in parallel, with time allocated to pre-planning and post-planning, which would impact the practice's limited resources.

All MIPS eligible clinicians would be allowed to self-identify as part of an APM, a patient-centered medical home or comparable specialty practice, a Medicaid Medical Home or Medical Home Model, a non-patient facing professional, a small practice (consisting of 15 or fewer professionals), a practice located in a rural area, or a practice in a geographic HPSA or any combination thereof as applicable during attestation following the performance period. We refer readers to https://innovation.cms.gov/​Medicare-Demonstrations/​Medicare-Medical-Home-Demonstration.html for more information on the Medical Home Model.

We would validate these self-identifications as appropriate. We propose that the following scoring would apply to MIPS eligible clinicians who are a non-patient facing professional, a small practice (consisting of 15 or fewer professionals), a practice located in a rural area, or practice in a geographic HPSA or any combination thereof:

Reporting of one medium-weighted or high-weighted activity would result in 50 percent of the highest potential score.

Reporting of two medium-weighted or high-weighted activities would result in 100 percent of the highest potential score.

In future years, we may adjust the weighting of activities at the MIPS eligible clinician level based on initial patterns of CPIA reporting. For example, if a MIPS eligible clinician reports on the same medium-weighted activity over several performance periods, in a subsequent year that MIPS eligible clinician may not be allowed to continue to select that same activity. This is because the intent of the CPIA performance category is to demonstrate improvement over time and not just demonstrate same benefit from year to year. For example, continuing to provide expanded practice access does not demonstrate improvement over time. Further, should the weighting of activities change in future years, we may also adjust the CPIA performance category point target accordingly. We request comment on our proposed approach to score the CPIA performance category. We also seek comment on alternative methodologies for the CPIA performance category. We seek to assure equity in scoring MIPS eligible clinicians while still considering activity variation, impact and burden.

(5) Scoring the Advancing Care Information Performance Category

We refer readers to section II.E.5.g.6. for our proposed methodology for scoring the advancing care information performance category. We reiterate that this methodology has many of the features of the unified scoring system described above. Specifically, we are moving away from the “all-or-nothing” scoring approach of the Medicare EHR Incentive Program. In addition, MIPS Start Printed Page 28268eligible clinicians would know in advance what they have to do to achieve points under the advancing care information performance category in MIPS. We provide a brief summary of our proposed scoring methodology here.

In the advancing care information performance category, we propose to score for both participation and performance. We refer to these scoring methods as the “base score” and the “performance score”.

To earn points toward the base score, a MIPS eligible clinician or group must report the numerator and denominator (or yes/no statement as applicable) for certain measures adopted by the EHR Incentive Programs in the 2015 EHR Incentive Programs Final Rule to achieve 50 percent of the total advancing care information performance category score. For measures that previously included a percentage-based threshold, we are not requiring MIPS eligible clinicians or groups to meet those thresholds. Instead we propose to require eligible clinicians and groups to report the numerator (of at least one) and denominator (or a yes/no statement for applicable measures) for each measure being reported.

For the base score, MIPS eligible clinicians or groups must meet Objective 1: Protect Patient Health Information and its associated measure in 2015 EHR Incentive Programs Final Rule. Additionally, eligible clinicians would be required to report the numerator and denominator, or a yes/no statement as appropriate, for each measure for Electronic Prescribing, Patient Electronic Access to Health Information, Coordination of Care Through Patient Engagement, Health Information Exchange, and Public Health and Clinical Data Registry Reporting— as adopted in the 2015 EHR Incentive Programs Final Rule. Failure to meet any of the objectives would result in a base score of zero and an advancing care information performance category score of zero.

For the Public Health and Clinical Data Registry Reporting objective, an eligible clinician or group is only required to report on the Immunization Registry Reporting measure. Completing any additional measures under the objective would earn one additional bonus point after calculation of the performance score.

The performance score is then determined in addition to the base score. The performance score methodology would implement a decile scale for the application of additional points based on performance in the objectives and measures for Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange. There are eight associated measures under these three objectives; each has a maximum of ten percentage points available. The total available performance score would be 80 percent which is, in combination with the base score of 50 percent, greater than the total possible performance category score of 100 percent. We have taken this approach in order to provide flexibility toward achieving the maximum score in the advancing care information performance category—however, a MIPS eligible clinician or group's score is capped at 100 percent.

This summary only represents the primary advancing care information performance category scoring proposal. For full details on the advancing care information performance category scoring and an explanation of alternatives considered, as well as accommodation for eligible clinicians planning to report Modified Stage 2 or use 2014 Edition CEHRT in 2017 please refer to II.E.5.g.4.

b. Calculating the Composite Performance Score (CPS)

Section II.E.6.a. of this rule describes our proposed methodology for assessing and scoring MIPS eligible clinician performance for each of the four performance categories. In this section, we propose the methodology to determine the CPS based on the scores for each of the four performance categories. We define at § 414.1305 the CPS as a composite assessment (using a scoring scale of 0 to 100) for each MIPS eligible clinician for a specific performance period determined using the methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards with respect to the applicable measures and activities for each applicable performance category. The CPS is the sum of the products of each performance category score and each performance category's assigned weight multiplied by 100.

(1) Formula To Calculate the CPS

Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards with respect to the applicable measures and activities with respect to each performance category applicable to such clinician for a performance period, and using the methodology, provide for a CPS (using a scoring scale of 0 to 100) for each MIPS eligible clinician for the performance period. Additionally, sections 1848(q)(5)(E) and (F) of the Act address the weights for each of the performance categories in the CPS.

To create a CPS from 0-100 based on the individual performance category scores, we propose to multiply the score for each performance category by the assigned weight for the performance category. We provide in Table 25 the weights for each performance category for the 2019, 2020 and 2021 MIPS payment years. The resulting weighted performance category scores would be summed to create a single CPS. As described in section II.E.2 of this preamble, we propose that the identifier for MIPS performance would be the same for all four performance categories, and therefore, the methodology to calculate a CPS would be the same for both individual and group performance.

The following equation summarizes the proposed CPS calculation at § 414.1380(c):

(a) Accounting for Risk Factors

Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, that section provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals' health status and other risk factors, assess appropriate adjustments to quality measures, resource use measures and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, CPSs, scores for performance categories or scores for measures or activities under the MIPS. In doing this, the Secretary is required to take into account the relevant studies conducted and recommendations made in reports under section 2(d) of the Improving Medicare Post-Acute Transformation (IMPACT) Act of 2014 and, as appropriate, other information, including information collected before completion of such studies and recommendations. HHS' Office of the Assistant Secretary for Planning and Evaluation (ASPE) is conducting studies and making recommendations on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the IMPACT Act and Start Printed Page 28269expects to issue a report to Congress by October 2016. We will closely examine the recommendations issued by ASPE and incorporate them as feasible and appropriate through future rulemaking. We also note that several MIPS measures, as appropriate, include risk adjustment in their measure specifications. For example, outcome measures in the quality performance category generally have risk adjustment embedded in the measure calculation specification, while process measures generally do not. Similarly, in the resource use performance category, the proposed total per capita costs for all attributed beneficiaries measure is adjusted for demographic and clinical factors. That measure also has a specialty adjustment that is applied after the measure calculation to account for differences in specialty mix within a practice. The MSPB measure and other resource use measures have different risk adjustments that are specific to the individual measure. For the first year of MIPS, for the quality and resource use performance categories, we propose to use the measure-specific risk adjustment for all measures (where applicable), as well as the additional specialty adjustment for the total per capita costs for all attributed beneficiaries.

We invite public comments on this proposal.

(2) CPS Performance Category Weights

(a) General Weights

Section 1848(q)(5)(E)(i) of the Act specifies weights for the performance categories included in the MIPS CPS: In general, 30 percent for the quality performance category, 30 percent for the resource use performance category, 25 percent for the advancing care information performance category, and 15 percent for the CPIA performance category. However, that section also specifies different weightings for the quality and resource use performance categories for the first and second years for which the MIPS applies to payments. Section 1848(q)(5)(E)(i)(II)(bb) of the Act specifies that for year 1, not more than 10 percent of the CPS will be based on the resource use performance category and for year 2, not more than 15 percent will be based on resource use performance category. Under section 1848(q)(5)(E)(i)(I)(bb) of the Act, the weight of the quality performance category for each of the first two years will increase by the difference of 30 percent minus the weight specified for the resource use performance category for the year.

In previous sections of this rule, we have proposed the performance category weights for the first MIPS payment year of 2019. In section II.E.5.e.2., we propose to set the resource use performance category weight at 10 percent for the 2019 payment year and 15 percent for the 2020 payment year. Correspondingly, in section II.E.5.b.2., we propose to set the quality performance category weight to 50 percent for the 2019 payment year and 45 percent for the 2020 payment. The quality performance category weight proposal is based on the 30 percent required by statute for the quality performance category plus 30 percent minus the weight of the resource use performance category, as required by section 1848(q)(5)(E)(i)(I)(bb) of the Act. As specified in section 1848(q)(5)(E)(i) of the Act, the weights for the other performance categories are 25 percent for the advancing care information performance category; and 15 percent for the CPIA performance category. Section 1848(q)(5)(E)(ii) of the Act provides that in any year in which the Secretary estimates that the proportion of eligible professionals (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under in section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the CPS, but not below 15 percent, and adjust the weighting of the other performance categories. We refer readers to our proposals concerning section 1848(q)(5)(E)(ii) of the Act in section II.E.5.g.(6)(e).

Table 25 summarizes the weights specified for each performance category under section 1848(q)(5)(E)(i) of the Act and in accordance with our proposals.

(b) Flexibility for Weighting Performance Categories

Under section 1848(q)(5)(F) of the Act, if there are not sufficient measures and activities applicable and available to each type of eligible clinician involved, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable and for each measure and activity based on the extent to which the measure or activity is applicable and available to the type of eligible clinician involved.

In section II.E.6.a and section II.E.5.g.8., we describe scenarios where certain MIPS eligible clinicians might not receive a performance category score in the quality, resource use, or advancing care information performance categories. We propose that in such scenarios we would use the authority under section 1848(q)(5)(F) of the Act to assign a weight of zero to the performance category and redistribute the weight for that performance category or categories as described in the next section.

For the quality and resource use performance categories, we believe having sufficient measures applicable Start Printed Page 28270and available means that we are able to reliably calculate a score for the measures that adequately captures and reflects the performance of the MIPS eligible clinician. For the quality and resource use performance categories, we propose in sections II.E.6.a.2.d., II.E.6.3.a., and II.E.6.a.3.d. that we would not calculate a performance category score if a MIPS eligible clinician does not have any measures with the required case minimum or any measures with a sufficient number of MIPS eligible clinicians to create a benchmark. Measures that do not meet the required case minimum or a sufficient number of MIPS eligible clinicians to create a benchmark would be excluded from scoring, and the MIPS eligible clinician would not receive a quality or resource use performance category score. (Note, this situation is different from a MIPS eligible clinician who elects not to submit any quality measures. A MIPS eligible clinician who elects not to submit any quality measures would receive a quality performance category score of zero.) We believe MIPS eligible clinicians who would have no scored measures for a performance category under our proposals would not have sufficient measures applicable and available for that performance category.

For the quality performance category, we anticipate that most MIPS eligible clinicians would select the measures most relevant to their practice and that in most cases, the measures they select would meet the required case minimum. We plan to monitor measure selection trends under the performance category and will revise this policy if it appears MIPS eligible clinicians are reporting measures that are not relevant to their practice or measures that do not meet the required case minimum. In the resource use performance category, we believe MIPS eligible clinicians who are not attributed enough cases to be reliably measured should not be scored for the performance category. We have proposed to include many resource use measures that we believe are sufficiently developed and ready for evaluating resource use by MIPS eligible clinicians; however, if a MIPS eligible clinician is not attributed any (or very few) cases for the measure, then we do not believe the MIPS eligible clinician should be measured on performance.

We refer readers to section II.E.5.g.8. of this proposed rule for a detailed discussion of the scenarios in which a MIPS eligible clinician may not have sufficient measures applicable and available under the advancing care information performance category. For the CPIA performance category, however, we envision that all MIPS eligible clinicians would have sufficient activities applicable and available and do not propose any scenario where a MIPS eligible clinician would not receive a CPIA performance category score.

In addition to scenarios where a MIPS eligible clinician would have no scored measures for a performance category, we believe there may be scenarios in which a MIPS eligible clinician would have too few scored measures under the quality performance category for us to reliably calculate a performance category score that is worth half the weight of the CPS for the 2019 MIPS payment year. We propose that if a MIPS eligible clinician has fewer than three scored quality measures (either submitted measures or measures calculated from administrative claims data) for a performance period, we would consider the MIPS eligible clinician not to have a sufficient number of measures applicable and available for the 2019 MIPS payment year quality performance category weight and would therefore lower the weight of the quality performance category. In this situation, the MIPS eligible clinician has a quality performance category score, but has data for only one or two scored measures, which is not a sufficient number of measures for the quality performance category because the quality performance category would constitute half of the CPS for the 2019 MIPS payment year. In addition, as described in the next section, for MIPS eligible clinicians that are not scored on the resource use or advancing care information performance category, we propose to increase the weight of the quality performance category. For these reasons, we believe that for the first year of MIPS, the quality performance category requires a sufficient number of measures to justify its weight in the CPS. We will reconsider this policy in future years as the weights for the performance categories change. We may consider implementing a similar policy for the resource use performance category for future years, but not for the first year of MIPS based upon the lower weighting of the resource use performance category.

In section II.E.5.b., we are proposing for the quality performance category, generally, that MIPS eligible clinicians submit a minimum of six measures for scoring in MIPS. In addition, we propose to include up to three population-based measures derived from claims data. As described in section II.E.6.a.2., a MIPS eligible clinician may submit a measure that is not scored, either because the measure did not meet the required case minimum to be reliably measured or because fewer than 20 MIPS eligible clinicians with sufficient volume submitted a measure through a similar reporting mechanism and a benchmark could not be created for the performance or baseline period. We reiterate that a measure that is not scored due to not meeting the required case minimum or lack of a measure benchmark, is different than a required measure that is not reported. Any required measure that is not reported or reported with in a way that does not meet the data completeness requirements would receive a score of zero points and would be considered a scored measure.

We are concerned that if a large percentage of the expected measures are not able to be scored due to not meeting the required case minimums or a missing benchmark, then just one or two measures would contribute disproportionately to the CPS because the quality performance category score is worth 30 to 50 percent (depending on the year) of the CPS under section 1848(q)(5)(E)(i) of the Act. We do not believe a score for one or two quality measures can capture all the elements of quality performance during a performance period. We believe the lack of a sufficient number of measures for scoring limits the value of quality performance measurement toward the CPS. Therefore, we propose that if a MIPS eligible clinician has only two scored measures (including both submitted measures and measures derived from administrative claims data) to reduce the weight of the quality performance category by one-fifth (for example, from 50 percent to 40 percent in year 1) and redistribute the weight (for example, 10 percent in year 1) proportionately to the other performance categories for which the MIPS eligible clinician did receive a performance category score. If a MIPS eligible clinician has only one scored quality measure, then we propose to reduce the weight of the quality performance category by two-fifths (for example, from 50 percent to 30 percent in year 1) and redistribute the weight (for example, 20 percent in year 1) proportionately to the other performance categories for which the MIPS eligible clinician did receive a performance category score. Lowering the weight of the quality performance category would be consistent with the relatively low percentage of expected quality measures that are able to be scored.

We request comment on these proposals to identify MIPS eligible clinicians without sufficient measures and activities applicable and available Start Printed Page 28271and our proposals to reweight those performance categories. We also seek comment on alternative methods for reweighting performance categories for MIPS eligible clinicians without sufficient measures and activities in certain performance categories. We seek to ensure that reweighting would not cause an eligible clinician to be either advantaged or disadvantaged due to a lack of sufficient measures and activities applicable and available, and a corresponding inability to generate a score for a certain performance category.

(c) Redistributing Performance Category Weights

We propose at § 414.1380(c)(3) to reweight the performance categories for MIPS eligible clinicians when there are not sufficient measures and activities applicable and available to them. We propose to reweight the performance categories in the following situations.

If the MIPS eligible clinician does not receive a resource use or advancing care information performance category score, and has at least three scored measures (either submitted measures or those calculated from administrative claims) in the quality performance category, then we propose to reassign the weights of the performance categories without a score to the quality performance category. We believe this policy is appropriate for several reasons. First, section 1848(q)(5)(E)(i)(I)(bb) of the Act redistributes weight from the resource use performance category to the quality performance category in the first two years of MIPS. This proposal is consistent with that redistribution logic. In addition, MIPS eligible clinicians have experience reporting quality measures through the PQRS program and measurement in this performance category is more mature. Finally, for the 2019 MIPS payment year, quality performance would be worth at least half of the CPS. By requiring the MIPS eligible clinician to have at least three scored quality measures, we believe the quality performance category would be robust enough to support more weight reassigned to it than other performance categories. We may revisit this policy in future years as the weight for the resource use performance category increases and the weight for the quality performance category decreases.

We also propose an alternative that does not reassign all the weight to the quality performance category, but rather reassigns the weight proportionately to each of the other performance categories for which the MIPS eligible clinician has received a performance category score.

We request public comments on the proposal to reassign the weights to the quality performance category, as well as the alternate proposal to redistribute proportionately to other performance categories.

If the MIPS eligible clinicians have fewer than three scored measures in the quality performance category score, then we propose to reassign the weights for the performance categories without scores proportionately to the other performance categories for which the MIPS eligible clinician has received a performance category score. We request comment on this proposal.

Finally, because the CPS is a composite score, we believe the intention of section 1848(q)(5) of the Act is for MIPS eligible clinicians to be scored based on multiple performance categories. Basing a CPS on a single performance category, even a robust and familiar performance category like quality, would frustrate that intent. In our proposals, CPIA is the only performance category which would always have a performance category score. We are particularly concerned about the possibility that a MIPS eligible clinician might, for the reasons discussed above, not have sufficient measures applicable and available for the quality, resource use, and advancing care information performance categories, and would only receive a score for the CPIA performance category. The CPIA performance category is based on activities that are reported by attestation, not on measured performance. In addition, because CPIA is not as mature as the other performance categories, each of which include certain aspects of existing CMS programs, we are unsure how much variation we will have in the CPIA performance category. We do not think it would be equitable to allow MIPS eligible clinicians that attest to receive the maximum points for that performance category and then base the CPS solely on the CPIA performance category. Such a scenario may result in higher CPS and payment adjustment factors for some MIPS eligible clinicians based solely on the CPIA performance category, while other MIPS eligible clinicians are measured based on their performance under the other performance categories. Therefore, we propose that if a MIPS eligible clinician receives a score for only one performance category, we would assign the MIPS eligible clinician a CPS that is equal to the performance threshold described in section II.E.5., which means the eligible clinician would receive a MIPS adjustment factor of 0 percent for the year. We anticipate this proposal would affect very few MIPS eligible clinicians in year 1 and even fewer in future years as more eligible clinicians are able to report on and receive scores for more of the performance categories.

We welcome public comment on this proposal.

7. MIPS Payment Adjustments

i. Payment Adjustment Identifier

As we describe in section II.E.2 of this preamble, we propose to allow MIPS eligible clinicians to measure performance as an individual, as a group defined by TIN, or as an APM Entity group using the APM scoring standard, yet for purposes of the application of the MIPS adjustment factors to payments in accordance with section 1848(q)(6)(E) of the Act (referred to as the payment adjustment), we are proposing to use a single identifier, TIN/NPI, for all MIPS eligible clinicians, regardless of whether the TIN/NPI was measured as an individual, group or APM Entity group. In other words, a TIN/NPI may receive a CPS based on individual, group, or APM Entity group performance, but the payment adjustment would be applied at the TIN/NPI level.

We are proposing to use the single identifier, TIN/NPI, for the payment adjustment for a few reasons. First, the final eligibility status of some clinicians would not be known until after the performance period ends. For example, the calculations to determine which clinicians would be excluded from MIPS, such as identifying clinicians that are QPs or are below the low-volume threshold, occur after the performance period ends. Using TIN/NPI would allow us to correctly identify which TIN/NPIs are still MIPS eligible clinicians after the exclusion criteria have been applied.

Second, the identifiers for measurement are not mutually exclusive and using TIN/NPI to apply the payment adjustment would allow us to resolve any inconsistencies that arise from the measurement identifiers. For example, a TIN may have 40 percent of its eligible clinicians participating in a MIPS APM and the remaining 60 percent are not participating in any APM. The TIN elects to submit performance information for all the eligible clinicians in the TIN, including those that are participating in the MIPS APM, so that it can ensure all of its eligible clinicians are being measured in MIPS. We cannot simply use the APM Start Printed Page 28272Entity and TIN identifiers because we either have eligible clinicians with duplicative data and overlapping scores, or we have portions of the measurement identifier carved out if we eliminate the overlap. In our example, the eligible clinicians participating in the MIPS APM would have data for two CPSs (one based on the APM Entity group performance and one based on the group TIN performance). The eligible clinicians not participating in the MIPS APM would have only one CPS (one based on the group TIN performance). Applying the payment adjustment at the TIN/NPI level provides us the flexibility to correctly identify and resolve the conflicts emerging when measurement identifiers overlap. The TIN/NPI identifier is mutually exclusive on all of our measurement identifier options; therefore, we believe this identifier can be consistently used for individual, group, or APM scoring standard identifiers. We refer readers to section II.E.2 for a discussion of identifiers and our proposals related to them.

ii. CPS Used in Payment Adjustment Calculation

Because we are proposing to use only TIN/NPI to apply the MIPS payment adjustments and because there is a gap between the performance period and the MIPS payment year, we believe we should assign the historical CPS to each TIN/NPI that is subject to MIPS for the payment year.

In general, we propose to use the CPS associated with the TIN/NPI combination in the performance period. For groups submitting data using the TIN identifier, we propose to apply the group CPS to all the TIN/NPI combinations that bill under that TIN during the performance period. For individual MIPS eligible clinicians submitting data using TIN/NPI, we propose to use the CPS associated with the TIN/NPI that is used during the performance period. For eligible clinicians in MIPS APMs, we propose to assign the APM Entity group's CPS to all the APM Entity Participant Identifiers that are associated with the APM Entity on December 31 of the performance period. We refer readers to section II.E.5.h for more information about the process to identify participating APM Entities. For eligible clinicians that participate in APMs for which the APM scoring standard does not apply, we propose to assign a CPS using either the individual or group data submission assignments described above.

In the case where a MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, there would be no corresponding historical performance information or CPS for the new TIN/NPI. Because we want to connect actual performance to the individual MIPS eligible clinician as often as possible, in cases where there is no CPS associated with a TIN/NPI from the performance period, we propose to use the NPI's performance for the TIN(s) the NPI was billing under during the performance period. If the MIPS eligible clinician has only one CPS associated with the NPI from the performance period, then we propose to use that CPS. For example, if a MIPS eligible clinician worked in one practice (TIN A) in the performance period, but is working at a new practice (TIN B) during the payment year, then we would use the CPS for the old practice (TIN A/NPI) to apply the MIPS payment adjustment for the NPI in the new practice (TIN B/NPI). This proposal most closely links the MIPS eligible clinician's performance during the performance period to the payment adjustment. It also ensures that MIPS eligible clinicians who qualify for a positive payment adjustment are able to keep it, even if they change practices. For those who have a negative payment adjustment, this proposal also ensures MIPS eligible clinicians are still accountable for their performance.

In scenarios where the MIPS eligible clinician billed under more than one TIN during the performance period, and the MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, we propose to use a weighted average CPS based on total allowed charges associated with the NPI from the performance period. This proposal would provide a CPS that is based on all the services the NPI billed to Medicare during the performance period. Table 26 presents an example of how this proposed approach would work. In this example, a MIPS eligible clinician (NPI) was assigned a CPS for two unique TIN/NPI combinations from the performance period (TIN A/NPI and TIN B/NPI). In the MIPS payment year, the eligible clinician is now billing for Medicare services under a third TIN/NPI combination without a previously calculated CPS (TIN C/NPI). In this case, the eligible clinician's MIPS adjustment for payments made to TIN C/NPI would be based on a weighted average of CPSs for TIN A/NPI and TIN B/NPI.

If an NPI did not have any allowed charges in the performance period, then the clinician would not be included in MIPS due to the low-volume exclusion.

We also propose an alternative proposal where in lieu of taking the Start Printed Page 28273weighted average, we take the highest CPS from the performance period, which would be a CPS of 67.5 in the above example which is the CPS for TIN A/NPI. We believe the alternative approach rewards eligible clinicians for their prior performance and may be easier to implement in year 1 of MIPS. Our concern with this approach is that the highest CPS may represent a relatively small portion of the eligible clinician's practice during the performance period.

We request comment on the proposal to use the CPSs associated with the TIN(s) the NPI was billing under during the performance period when the TIN/NPI does not have a CPS from the performance period. We also request comment on our proposal to use a weighted average, and the alternative proposal to select the highest CPS from the performance period.

We also considered, but are not proposing, a policy to have the performance follow the group (TIN) rather than the individual (NPI). In other words, the MIPS eligible clinician's performance would be based on the historical performance of the new TIN that the MIPS eligible clinician moved to after the performance period, even though the MIPS eligible clinician was not part of this group during the performance period. This policy is consistent with the policy for the VM and would create incentives for MIPS eligible clinicians to move to higher performing practices (77 FR 69308). We also believe this policy would provide a lower burden for practice administrators as all MIPS eligible clinicians in the TIN would have the same payment adjustment. On the other hand, having performance follow the TIN creates some challenges. We are concerned that MIPS eligible clinicians who earned a positive adjustment based on their performance during the performance period would not retain the positive adjustment if the new TIN had a lower CPS. Finally, we believe that having performance follow the TIN could create some unanticipated issues with budget neutrality if high-performing TINs expand. For all of these reasons, we are not proposing to have performance follow the TIN, but rather have performance follow the NPI; however, we seek comment on this option.

In some cases, a TIN/NPI could have more than one CPS associated with it from the performance period, if the eligible clinician submitted duplicative data sets. In this situation, the MIPS eligible clinician has not changed practices, rather for example, a MIPS eligible clinician has a CPS for an APM Entity and a CPS for a group TIN. If a MIPS eligible clinician has multiple CPSs, we propose a multi-pronged approach to select the CPS that would be used to determine the MIPS payment adjustment. First, we propose that if a MIPS eligible clinician is a participant in MIPS APM, then the APM Entity CPS would be used instead of any other CPS (such as a group TIN CPS or individual CPS). We propose that if a MIPS eligible clinician has more than one APM Entity CPS for the same TIN (by participating in multiple MIPS APMs), we would apply the highest APM Entity CPS to the eligible clinician. Second, if a MIPS eligible clinician reports as a group and as an individual, we would calculate a CPS for the group and individual identifier and use the highest CPS for the TIN/NPI. We request comment on this proposed approach.

b. MIPS Adjustment Factors

Section 1848(q)(6)(A) of the Act requires the Secretary to specify a MIPS adjustment factor for each MIPS eligible clinician for a year determined by comparing the CPS of the MIPS eligible clinician for such year to the performance threshold established under paragraph (D)(i) for such year, in a manner such that the adjustment factors specified for a year result in differential payments. Section 1848(q)(6)(A)(iii) of the Act provides that MIPS eligible clinicians with CPS at or above the performance threshold receive a zero or positive adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a CPS at the performance threshold and an adjustment factor of the applicable percent is assigned for a CPS of 100. Section 1848(q)(6)(A)(iv) of the Act provides that MIPS eligible clinicians with CPS below the performance threshold receive a negative payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a CPS at the performance threshold and an adjustment factor of the negative of the applicable percent is assigned for a CPS of 0; further, MIPS eligible clinicians with CPS that are equal to or greater than zero, but not greater than one-fourth of the performance threshold, receive a negative payment adjustment factor that is equal to the negative of the applicable percent.

Section 1848(q)(6)(B) of the Act defines the applicable percent for each year as follows: (i) For 2019, 4 percent; (ii) for 2020, 5 percent; (iii) for 2021, 7 percent; and (iv) for 2022 and subsequent years, 9 percent.

Section 1848(q)(6)(C) of the Act provides for an additional positive MIPS adjustment factor for exceptional performance, for each of the years 2019 through 2024, for each MIPS eligible clinician with a CPS for a year at or above the additional performance threshold under paragraph (D)(ii) for such year. The additional MIPS adjustment factor shall be in the form of a percent and determined in a manner such that eligible clinicians having higher CPS above the additional performance threshold receive higher additional MIPS adjustment factors.

c. Determining the Performance Thresholds

(1) Establishing the Performance Threshold

Under section 1848(q)(6)(D)(i) of the Act, for each year of the MIPS, the Secretary shall compute a performance threshold with respect to which the CPS of MIPS eligible clinicians are compared for purposes of determining the MIPS adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, which may be reassessed every three years) of the CPS for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act outlines a special rule for the initial two years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS adjustment factors under paragraph (A) and an additional performance threshold for purposes of determining the additional MIPS adjustment factors under paragraph (C), each of which shall be based on a period prior to the performance periods and take into account data available with respect to performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary.

We define the term performance threshold at § 414.1305, as the level of performance that is established for a performance period at the CPS level. CPSs above the performance threshold receive a positive MIPS adjustment factor and CPSs below the performance threshold receive a negative MIPS adjustment factor. CPSs that are equal to or greater than 0, but not greater than one-fourth of the performance threshold receive the maximum negative MIPS adjustment factor for the MIPS payment year. CPSs at the performance threshold Start Printed Page 28274receive a neutral MIPS adjustment factor.

To establish the performance threshold for the 2019 MIPS payment year, we propose to model 2014 and 2015 Part B allowed charges, 2014 and 2015 PQRS data submissions, 2014 and 2015 QRUR and sQRUR feedback data, and 2014 and 2015 Medicare and Medicaid EHR Incentive Program data to inform where the performance threshold should be. We would use this data to estimate the impact of the quality and resource use scoring proposals. We would also use the EHR Incentive Program information to estimate which MIPS eligible clinicians are likely to receive points for the advancing care information performance category. Because of the lack of historical data for the CPIA performance category, we would apply some sensitivity analyses to help inform where the performance threshold should be.

For the 2019 MIPS payment year, we propose to set the performance threshold at a level where approximately half of the eligible clinicians would be below the performance threshold and half would be above the performance threshold, which we believe is consistent with the intent of section 1848(q)(6)(D)(i) of the Act which requires the performance threshold in year 3 and beyond to be equal to the mean or median of CPS from a prior period. We also considered other policy options when setting the performance threshold. For example, we considered setting the performance threshold so that the scaling factor (which is described in section II.E.7.b) is 1.0. We could set the performance threshold based on policy goals to ensure a minimum number of points are earned before an eligible clinician is able to receive a positive adjustment factor and potentially an additional adjustment factor for exceptional performance. We seek comment on the policy options for setting the performance threshold.

We would determine the performance threshold in accordance with the methodology established in the final rule. We intend to publish the performance threshold on the CMS Web site prior to the performance period.

(2) Additional Performance Threshold for Exceptional Performance

In addition to the performance threshold, section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS, an additional performance threshold for purposes of determining the additional positive MIPS adjustment factors for exceptional performance under paragraph (C). For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold: (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible CPS above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score that is equal to the 25th percentile of the actual CPS for MIPS eligible clinicians with CPS at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act.

We define at § 414.1305 the additional performance threshold as an additional level of performance, in addition to the performance threshold, for a performance period at the CPS level at or above which a MIPS eligible clinician may receive an additional positive MIPS adjustment factor. For each year of the MIPS, we will compute an additional performance threshold for purposes of determining the additional MIPS adjustment factors under section 1848(q)(6)(C) of the Act. We propose at § 414.1405(e) the following methods for computing the additional performance threshold: the threshold shall be equal to the 25th percentile of the range of possible CPS above the performance threshold; or it shall be equal to the 25th percentile of the actual CPS for MIPS eligible clinicians with CPS at or above the performance threshold with respect to the prior period used to determine the performance threshold.

As discussed above, section 1848(q)(6)(D)(iii) of the Act outlines a special rule for establishing the additional performance threshold for the initial two years of MIPS. Because 2019 is the first MIPS payment year, we do not have any actual CPS for MIPS eligible clinicians to use for purposes of defining an additional performance threshold under the methodology proposed above. Therefore, we propose to establish the additional performance threshold at the 25th percentile of the range of possible CPS above the performance threshold. For example, if the performance threshold is 60, then the range of possible CPS above the performance threshold would be 61-100. The 25th percentile of those possible values is 70. We intend to publish the exceptional performance threshold with the performance threshold prior to the performance period.

d. Scaling/Budget Neutrality

Section 1848(q)(6)(F)(i) of the Act provides, with respect to positive MIPS adjustment factors for eligible clinicians whose CPS is above the performance threshold under paragraph (D)(i) for such year, the Secretary shall increase or decrease such adjustment factors by a scaling factor (not to exceed 3.0) in order to ensure that the budget neutrality requirement of clause (ii) is met. Stated generally, budget neutrality as required by section 1848(q)(6)(F)(ii) of the Act means the estimated increase in the aggregate allowed charges resulting from the application of positive MIPS adjustment factors under paragraph (A) (after application of the scaling factor) is equal to the estimated decrease in the aggregate allowed charges resulting from the application of negative MIPS adjustment factors under paragraph (A). Under section 1848(q)(6)(F)(iii) of the Act, budget neutrality requirements shall not apply if all MIPS eligible clinicians receive CPS for a year that are below the performance threshold under paragraph (D)(i) for such year, or if the maximum scaling factor (3.0) is applied for a year.

e. Additional Adjustment Factors

Section 1848(q)(6)(C) of the Act requires, for each of the years 2019 through 2024, the Secretary to specify an additional positive MIPS adjustment factor for each MIPS eligible clinician whose CPS for a year is at or above the additional performance threshold established under paragraph (D)(ii) for that year. This additional adjustment factor is required to take the form of a percentage and to be determined by the Secretary such that MIPS eligible clinicians with higher CPS above the additional performance threshold receive higher additional MIPS adjustment factors. Section 1848(q)(6)(F)(iv)(I) of the Act provides, in specifying the additional adjustment factors under paragraph (C) for each applicable MIPS eligible clinician for a year, the Secretary shall ensure that the estimated aggregate increase in payments under Part B resulting from the application of such additional adjustment factors shall be equal to $500,000,000 for each year beginning with 2019 and ending with 2024. We refer to the $500,000,000 increase in payments as aggregate incentive payments. Section 1848(q)(6)(F)(iv)(II) of the Act provides that the additional adjustment factor for each applicable MIPS eligible clinician shall not exceed 10 percent, which may result in an aggregate increase in payments that is less than $500,000,000 as described in subclause (I).

To be consistent with the MIPS adjustment factors under section 1848(q)(6)(A) of the Act, we propose to Start Printed Page 28275apply a linear sliding scale where MIPS eligible clinicians with a CPS at the additional performance threshold would receive 0.5 percent additional adjustment factor and MIPS eligible clinicians with a CPS equal to 100 would receive a 10 percent maximum additional adjustment factor. Similar to the adjustment factor, we would apply a scaling factor that is greater than 0 and less than or equal to 1.0 if needed to ensure distribution of the $500,000,000 increase in payments. The scaling factor must be greater than 0 to ensure that MIPS eligible clinicians with higher CPS receive a higher additional adjustment factor. The scaling factor cannot exceed 1.0; the 10 percent maximum additional adjustment factor could only decrease and not increase because section 1848(q)(6)(F)(iv)(II) of the Act provides that the additional adjustment factor shall not exceed 10 percent. We are proposing the starting point for the additional adjustment factor at 0.5 percent for a CPS at the additional performance threshold because this would provide a large enough incentive for MIPS eligible clinicians to strive for the additional performance threshold, while still providing the opportunity for a positive slope on the linear sliding scale. If we are unable to achieve a linear sliding scale starting at 0.5 percent (because the estimated aggregate increase in payments for a year would exceed $500 million), then we propose to lower the starting percentage for a CPS at the additional performance threshold until we are able to create the linear sliding scale with a scaling factor greater than 0 and less than or equal to 1.0. A MIPS eligible clinician with a CPS that is below the additional performance threshold would not be eligible for an additional adjustment factor. We request comments on these proposals.

f. Application of the MIPS Adjustment Factors

Section 1848(q)(6)(E) of the Act provides that for items and services furnished by a MIPS eligible clinician during a year (beginning with 2019), the amount otherwise paid under Part B with respect to such items and services and MIPS eligible clinician for such year, shall be multiplied by 1 plus the sum of the MIPS adjustment factor determined under paragraph (A) divided by 100, and as applicable, the additional MIPS adjustment factor determined under paragraph (C) divided by 100. We would apply the adjustment factors in accordance with section 1848(q)(6)(E) of the Act.

We request comment on our proposals.

g. Example of Adjustment Factors

Figure A provides an example of how various CPS would be converted to an adjustment factor and potentially an additional adjustment factor, using the statutory formula. In this example, the performance threshold is 60. The applicable percentage is 4 percent for 2019. The adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest negative applicable percentage (negative 4 percent for 2019), and 100 being the highest positive applicable percentage. However, there are two modifications to this linear sliding scale. First, there is an exception for a CPS between 0 and 1/4 of the performance threshold (0-15 in our example). All MIPS eligible clinicians with a CPS in this range would receive the lowest negative applicable percentage (negative 4 percent for 2019). Second, the linear sliding scale line for the positive adjustment factor is adjusted by the scaling factor (which is determined by the formula described in section II.E.7.c.) If the scaling factor is greater than 0 and less than or equal to 1.0, then the adjustment factor for a CPS of 100 would be less than or equal to 4 percent. If the scaling factor is above 1.0, but less than or equal to 3.0, then the adjustment factor for a CPS of 100 would be higher than 4 percent. Only those MIPS eligible clinicians with a CPS equal to 60 (which is the performance threshold in this example) would receive no adjustment. In Figure A, the scaling factor for the adjustment factor is 1.37. MIPS eligible clinicians with a CPS equal to 100 would have an adjustment of 5.5 percent (4.0 percent × 1.37).

For the performance threshold of 60, the additional performance threshold for exceptional performance is 70. A CPS of 70 would have an additional adjustment factor of 0.5 percent, and the amount of the additional adjustment factor would increase to 10 percent times a scaling factor that is greater than 0 and less than or equal to 1.0. In Figure A, the scaling factor for the additional adjustment factor is 0.32. Therefore, MIPS eligible clinicians with a CPS of 100 would have an additional adjustment of 3.2 percent (10 percent × 0.32). The total adjustment for a MIPS eligible clinician with a CPS equal to 100 would be 1 + 0.055 + 0.032 = 1.087, for a total positive adjustment of 8.7 percent.

Start Printed Page 28276

Note:

The adjustment factor for CPS values above the performance threshold is illustrative. For MIPS eligible clinicians with a CPS of 100, the adjustment factor would be 4 percent times a scaling factor greater than 0 and less than or equal to 3.0. The scaling factor is intended to ensure budget neutrality, but cannot be higher than 3.0. The additional adjustment factor is also illustrative. The additional adjustment factor starts at 0.5 percent and cannot exceed 10 percent.

The final MIPS payment adjustments would be determined by the distribution of CPS across MIPS eligible clinicians and the performance threshold. More MIPS eligible clinicians above the performance threshold means the scaling factors would decrease because more MIPS eligible clinicians receive a positive adjustment. More MIPS eligible clinicians below the performance threshold means the scaling factors would increase because more MIPS eligible clinicians would have negative adjustments and relatively fewer MIPS eligible clinicians receive positive adjustments.

We request comment on our proposals.

8. Review and Correction of MIPS Composite Performance Score

a. Feedback and Information To Improve Performance

Through the MIPS and APMs RFI, we solicited comment on various questions related to performance feedback under section 1848(q)(12) of the Act, such as what type of information should be contained in the performance feedback data, how often the feedback should be made available, and who should be able to access the data. Several commenters stated that it would be beneficial if the performance feedback under MIPS contained all the data that contributes to an EP's CPS and any MIPS adjustment. Further, several commenters suggested that performance feedback allow for interactive use of the data. Commenters supported frequent availability of such data and many noted that a minimum of quarterly feedback data would be preferred. Commenters also noted that access to PQRS Feedback Reports currently was a challenge and some suggested that the EPs should be able to control who can access the feedback reports.

(1) Performance Feedback

(a) MIPS Eligible Clinicians

Under section 1848(q)(12)(A)(i) of the Act, as added by section 101(c)(1) of the MACRA, we are at a minimum required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and resource use performance categories beginning July 1, 2017, and we have discretion to provide such feedback regarding the CPIA and advancing care information performance categories.

Beginning July 1, 2017, we propose to include information on the quality and resource use performance categories in the performance feedback. Within these performance categories, we propose to use fields similar (that is, quality and resource use) to those currently available in the Quality and Resource Use Reports (QRURs). Since the QRURs already provide information on quality and resource use we believe this is a good starting point for the data fields to be included in the performance feedback. Additional information on the current QRURs can be found at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeedbackProgram/​Obtain-2013-QRUR.html.

The first performance feedback is due on July 1, 2017. As this is prior to us having received any MIPS data, we propose to initially provide feedback to MIPS eligible clinicians who are participating in MIPS using historical data set(s), as available and applicable. For example, these historical data set(s) could be a baseline report, using data based off performance that occurred in CY 2015 or CY 2016 for applicable and available quality and resource use data. In the event that 2017 is the first MIPS performance period (as proposed in section II.E.4. of this rule), we would not anticipate receiving the first set of Start Printed Page 28277data for MIPS until 2018 (as proposed in section II.E.5. of this rule). At a minimum for the first year, we propose to provide performance feedback on an annual basis since the first performance feedback, required on July 1, 2017 would be based on historic data set(s). As the program evolves, and we can operationally assess/analyze the MIPS data, we may consider in future years providing performance feedback on a more frequent basis, such as quarterly. Section 1848(q)(12)(A)(i) of the Act requires the performance feedback to be provided “timely” (such as quarterly), which is our goal as MIPS evolves. In addition, we seek comments on whether we should include first year measures in the performance feedback, meaning new measures that have been in use for less than 1 year, regardless of submission methods. The reasoning behind first-year measures potentially not being reported is we need to review the data from the measure before this data is incorporated into performance feedback, as we want to ensure the data we are providing in the performance feedback is useful and has usability for our stakeholders. We request comments on these proposals.

In future years and as the program evolves, we intend to seek comment on the template, including but not limited to the data fields, for performance feedback. While section 1848(q)(12)(A)(i) of the Act only requires us to provide performance feedback for the quality and resource use performance categories, we understand that the CPIA and advancing care information performance categories are important MIPS data. Commenters to the MIPS and APMs RFI noted that CMS should consult with stakeholders to ensure this performance feedback is useful before this data is provided to MIPS eligible clinicians. Therefore, we may consider including feedback on the performance categories of CPIA and advancing care information in future years. Further, before we consider adding CPIA and advancing care information data to the performance feedback we would like to engage in stakeholder outreach to understand what data fields might be helpful and usable to MIPS eligible clinicians. Regarding the MIPS CPS, this is something we are targeting to provide annually as part of the performance feedback as the program evolves. As technically feasible, we are also planning to provide data fields such as the CPS and each of the four performance categories in future performance feedback once MIPS data becomes available. In addition, we plan to explore the possibility of including the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) in future performance feedback. We seek comment on the frequency with which this performance feedback should be provided, considerations for including CPIA and advancing care information, and data fields that should be included in the performance feedback as this program evolves.

(b) APM Entities

We proposed in section II.E.5.h.(15) of this rule that MIPS eligible clinicians who participate in APM Entities would receive performance feedback, as technically feasible.

(2) Mechanisms

Under section 1848(q)(12)(A)(ii) of the Act, the Secretary may use one or more mechanisms to make performance feedback available, which may include use of a web-based portal or other mechanisms determined appropriate by the Secretary. For the quality performance category, described in section 1848(q)(2)(A)(i) of the Act, the feedback shall, to the extent an eligible clinician chooses to participate in a data registry for purposes of MIPS (including registries under sections 1848(k) and (m)) of the Act, be provided based on performance on quality measures reported through the use of such registries. With respect to any other performance category (that is, resource use, CPIA, or advancing care information), the Secretary shall encourage provision of feedback through qualified clinical data registries (QCDRs) as described in sections 1848(m)(3)(E) of the Act.

We understand that the PQRS and VM programs have employed various communication strategies to notify health care providers of the availability of their PQRS Feedback Reports and QRURs, respectively, through the CMS portal. However, many health care providers are still unaware of these reports and/or have difficulty accessing their reports in the portal. Further, we are aware that some health care providers perceive the current reports as complex and often difficult to understand; while others find the QRURs, and the drill down data included in them on the Medicare beneficiaries they serve, very useful. We are continuing to work with stakeholders to improve the usability of these reports. As we transition to MIPS, we are committed to ensuring that eligible clinicians are able to access their performance feedback, and that the data are easy to understand while providing information that will help drive quality improvement. We propose to initially make performance feedback available using a CMS designated system, such as a web-based portal; if technically feasible perhaps an interactive dashboard. As further discussed in section II.E.7.e. of this proposed rule, we also propose to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians, where applicable. At this time, we believe that these additional mechanisms will only be able to provide information on the quality performance category for MIPS in regard to performance feedback.

We plan to coordinate with third party intermediaries such as health IT vendors and QCDRs as MIPS evolves to enable additional feedback to be sent on the resource use, advancing care information and CPIA performance categories. We seek comment on this for future rulemaking.

Comments received through the MIPS and APMs RFI noted issues associated with access to the current Feedback Reports for PQRS. Specifically, comments were received noting issues with Enterprise Identity Management (EIDM) and access to the portal to view PQRS Feedback Reports. Commenters also noted the need for a mechanism to be put in place to notify EPs when their PQRS Feedback Report is available. We propose to use the information contained in the provider or supplier's Medicare enrollment records, and stored in the Provider Enrollment, Chain, and Ownership System (PECOS), as the system of records for eligible clinicians' contact information that should be used when the MIPS performance feedback is available. It is therefore critical that eligible clinicians ensure that their Medicare enrollment records (especially in regard to phone and email contact information) are updated, meaning current, on a consistent basis in PECOS. If more than one email address is listed, then the email address that should be used for communication should be designated. We also intend to provide education and outreach on how to access performance feedback. We seek comment on additional means that could be used to notify or contact MIPS eligible clinicians and groups when their performance feedback is available.

(3) Use of Data

Under section 1848(q)(12)(A)(iii) of the Act, for purposes of providing performance feedback, the Secretary may use data, for a MIPS eligible clinician, from periods prior to the Start Printed Page 28278current performance period and may use rolling periods in order to make illustrative calculations about the performance of such professional. We believe “illustrative calculations” means an interim, snap shot in time of performance, or perhaps a “dry-run” of the data including measure rates. This would provide an indication of how a MIPS eligible clinician might be performing, but would not be conclusive. Since MIPS will not likely have comparable data until year 3 of the program, these “illustrative calculations” could be based on historical data sets available to CMS until actual data for MIPS is available.

(4) Disclosure Exemption

As stated under section 1848(q)(12)(A)(iv) of the Act, feedback made available under section 1848(q)(12)(A) of the Act shall be exempt from disclosure under 5 U.S.C. 552 (the Freedom of Information Act).

(5) Receipt of Information

Section 1848(q)(12)(A)(v) of the Act, states that the Secretary may use the mechanisms established under section 1848(q)(12)(A)(ii) of the Act to receive information from professionals. This allows for expanded use of the feedback mechanism to not only provide feedback on performance to eligible clinicians, but to also receive information from professionals.

We intend to explore the possibility of adding this feature to the CMS designated system, such as a portal, in future years under MIPS. This feature could be a mechanism where eligible clinicians can send their feedback (that is, if they are experiencing issues accessing their data, technical questions about their data, etc.) to CMS. We appreciate that eligible clinicians may have questions regarding the information contained in their performance feedback. In order to assist eligible clinicians, we intend to establish resources, such as a helpdesk or offer technical assistance, to help address questions with the goal of linking these resource features to the CMS designated system, such as a portal.

Additionally, we seek comment on the types of information eligible clinicians would like to send to CMS via this mechanism.

(6) Additional Information—Type of Information

Section 1848(q)(12)(B)(i) of the Act, states that beginning July 1, 2018, the Secretary shall make available to MIPS eligible clinicians information about the items and services for which payment is made under Title 18 that are furnished to individuals who are patients of MIPS eligible clinicians by other suppliers and providers of services. This information may be made available through mechanisms determined appropriate by the Secretary, such as the proposed CMS designated system that would also provide performance feedback. Section 1848(q)(12)(B)(ii) of the Act specifies that the type of information provided may include the name of such providers, the types of items and services furnished, and the dates items and services were furnished. Historical data regarding the total, and components of, allowed charges (and other figures as determined appropriate by the Secretary) may also be provided. We seek comment on the type of information MIPS eligible clinicians would find useful and the preferred mechanisms to provide such information, as well as, arrangements that should be in place regarding this data (that is, eligible clinicians sharing data). We also seek comment as to whether additional information regarding beneficiaries attributed to a MIPS eligible clinician under the resource use performance category or information about which MIPS eligible clinician(s) beneficiaries to whom a given MIPS eligible clinician provides services were attributed would be useful feedback in regards to quality improvement efforts.

(7) Performance Feedback Template

The performance feedback under section 1848(q)(12)(A) of the Act is meant to be meaningful and usable to eligible clinicians. In an effort to ensure these data are tailored to the needs of eligible clinicians, we solicited comment through the MIPS and APMs RFI and received numerous comments regarding overall format of the performance feedback template. Suggestions were made on what this feedback should include for MIPS. We intend to collaborate with stakeholders outside of notice-and-comment rulemaking on how the performance feedback should look for MIPS; as well as, what data elements would be useful for eligible clinicians. We seek comment on the fields that should be included in the performance feedback template for MIPS eligible clinicians.

b. Announcement of Result of Adjustments

Section 1848(q)(7) of the Act requires that under the MIPS, the Secretary shall, not later than 30 days prior to January 1 of the year involved, make available to MIPS eligible clinicians the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) applicable to the eligible clinician for items and services furnished by the professional for such year. The Secretary may include such information in the confidential feedback under section 1848(q)(12) of the Act.

If technically feasible, we propose to include the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) in the performance feedback for eligible clinicians provided under section 1848(q)(12)(A) of the Act. If it is not technically feasible to provide this information in the performance feedback, we propose to make it available through another mechanism as determined appropriate by the Secretary (such as a portal or a CMS designated Web site) and seek comment on mechanisms that might be appropriate. The first announcement will be available no later than December 1, 2018 to meet statutory requirements. We request comment on these proposals.

c. Targeted Review

Section 1848(q)(13)(A) of the Act requires the establishment of a process under which a MIPS eligible clinician may seek an informal review of the calculation of the MIPS adjustment factor (or factors) applicable to such MIPS eligible clinician for a year.

We recognize that a principled approach to requesting and conducting a targeted review is required under the MACRA in order to minimize burdens on MIPS eligible clinicians and ensure transparency under MIPS. We also believe it is important to retain the flexibility to modify MIPS eligible clinicians' CPS or payment adjustment based on the results of targeted review. This will lend confidence to the determination of the CPS and payment adjustments, as well as, providing finality for the MIPS eligible clinician after the targeted review is completed. It will also minimize the need for claims reprocessing. We are proposing an approach below that outlines the factors that we would use to determine if a targeted review may be conducted. In keeping with the statutory direction that this process be “informal,” we have attempted to minimize the associated burden on the MIPS eligible clinician to the extent possible.

In accordance with section 1848(q)(13)(A) of the Act, we propose at § 414.1385 to adopt a targeted review process under MIPS wherein a MIPS eligible clinician may request that we review the calculation of the MIPS adjustment factor under section 1848(q)(6)(A) of the Act and, as applicable, the calculation of the additional MIPS adjustment factor Start Printed Page 28279under section 1848(q)(6)(C) of the Act applicable to such MIPS eligible clinician for a year. Because this review will be limited to the calculation of the MIPS adjustment factor and, as applicable, the additional MIPS adjustment factor, we anticipate we may find it necessary to review data related to the measures and activities and the calculation of the CPS according to the defined methodology. The following are examples of circumstances under which a MIPS eligible clinician may wish to request a targeted review. This is not a comprehensive list of circumstances:

The MIPS eligible clinician believes that measures or activities submitted to CMS during the submission period and used in the calculations of the CPS and determination of the adjustment factors have calculation errors or data quality issues. These submissions could be with or without the assistance of a third party intermediary; or

The MIPS eligible clinician believes that there are certain errors made by CMS, such as performance category scores were wrongly assigned to the MIPS eligible clinician (for example, the MIPS eligible clinician should have been subject to the low-volume threshold exclusion and should not have received a performance category score).

We believe that a fair targeted review request process requires accessibility to all MIPS eligible clinicians within a reasonable period of time and provides electronic and telephonic communication for questions regarding the targeted review process, as well as for the actual request for review and receipt of the decision on that request. The targeted review process will use the same help desk support mechanism as is provided for MIPS as a whole.

We further propose at § 414.1385 to adopt the following general process for targeted reviews under section 1848(q)(13)(A):

A MIPS eligible clinician electing to request a targeted review may submit their request within 60 days (or a longer period specified by us) after the close of the data submission period. All requests for targeted review must be submitted by July 31 after the close of the data submission period or by a later date that we specify in guidance.

We will provide a response with our decision on whether or not a targeted review is warranted. If a targeted review is warranted, the timeline for completing that review may be dependent on the number of reviews requested (for example, multiple reviews versus a single review by one MIPS eligible clinician) and general nature of the review.

As this process is informal and the statute does not require a formal appeals process, we will not include a hearing process. The MIPS eligible clinician may submit additional information to assist in their targeted review at the time of request. If we or our contractors request additional information from the MIPS eligible clinician, the supporting information must be received from the MIPS eligible clinician by us or our contractors within 10 calendar days of the request. Non-responsiveness to the request for additional information will result in the closure of that targeted review request, although another review request may be submitted if the targeted review submission deadline has not passed.

Since this is an informal review process and given the limitations on review under section 1848(q)(13)(B) of the Act, decisions based on the targeted review will be final, and there will be no further review or appeal.

If a request for targeted review is approved, the outcome of such review may vary. For example, we may determine that the clinician should have been excluded from MIPS, re-distribute the weights of certain performance categories within the CPS (for example, if a performance category should have been weighted at zero), or recalculate a performance category score in accordance with the scoring methodology for the affected category, if technically feasible.

We request comments on these proposals.

d. Review Limitation

Section 1848(q)(13)(B) of the Act, as added by section 101(c)(1) of the MACRA, provides there shall be no administrative or judicial review under sections 1869 and 1878 of the Act, or otherwise of the following:

The methodology used to determine the amount of the MIPS adjustment factor and the amount of the additional MIPS adjustment factor and the determination of such amounts;

The establishment of the performance standards and the performance period;

The identification of measures and activities specified for a MIPS performance category and information made public or posted on our Physician Compare Web site; and

The methodology developed that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.

We propose at § 414.1385 to implement these provisions as written in the statute.

We would reject any requests for targeted review under section 1848(q)(13)(A) of the Act that focus on the areas precluded from review under section 1848(q)(13)(B) of the Act. We request comments on this proposal.

e. Data Validation and Auditing

Our experience with the PQRS, VM and Medicare EHR Incentive Programs, has demonstrated the value of data validation and auditing as an important part of program integrity, which is necessary to ensure valid, reliable data. The current voluntary data validation process for PQRS and the audit process for the Medicare EHR Incentive Program are multi-step processes. We communicate the types of data elements that may be included for data validation across multiple Web sites and our documents. This includes defining specific data that may be abstracted from the certified EHR technology, as well as other documented records.

As we begin the MIPS, our strategy is to combine our past program integrity processes of the data validation process used in PQRS, and the auditing process used in the Medicare EHR Incentive Program into one set of requirements for MIPS eligible clinicians and groups, which we refer to as “data validation and auditing.” Based on our need for valid and reliable data on which to base a MIPS eligible clinician's or group's payment, we propose certain requirements for MIPS eligible clinicians and groups submitting data for the 2017 performance period (see section II.E.4) under MIPS. Further, we propose at § 414.1390 to selectively audit MIPS eligible clinicians on a yearly basis, and that if a MIPS eligible clinician or group is selected for audit, the MIPS eligible clinician or group would be required to do the following in accordance with applicable law:

Comply with data sharing requests, providing all data as requested by us or our designated entity. All data must be shared with CMS or our designated entity within 10 business days or an alternate time frame that is agreed to by CMS and the MIPS eligible clinician or group. Data would be submitted via email, facsimile, or an electronic method via a secure Web site maintained by CMS.

Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives and activities. Primary source documentation also may include verification of records for Medicare and Start Printed Page 28280non-Medicare beneficiaries where applicable.

We propose that we would monitor MIPS eligible clinicians and groups on an ongoing basis for data validation, auditing, program integrity issues and instances of non-compliance with MIPS requirements. If a MIPS eligible clinician or group is found to have submitted inaccurate data for MIPS, we propose that we would reopen, revise, and recoup any resulting overpayments in accordance with the rules set forth at § 405.980 (re-opening rules), § 450.982 and § 450.984 (revising rules); and § 405.370 and § 405.373 (recoupment rules). It is important to note that at § 405.980(b)(3) there is an exception whereby we have the authority to re-open at any time for fraud or similar fault. If we re-open the initial determination we must revise it, and send out a notice of the revised determination under § 450.982. We also propose that we would recoup any payments from the MIPS eligible clinician by the amount of any debts owed to us by the MIPS eligible clinician and likewise, we would recoup any payments from the group by the amount of any debts owed to us by the group. We also note that we would need to limit each such data validation and audit request to the minimum data necessary to conduct validation.

We propose all MIPS eligible clinicians and groups that submit data to CMS electronically must attest to the accuracy and completeness to the best of their knowledge of any data submitted to us. This attestation will occur prior to any electronic data submissions, via a Web site maintained by CMS.

We request comments on these proposals.

9. Third Party Data Submission

One of our strategic goals in developing MIPS includes developing a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is through flexible reporting options to accommodate different practices and make measurement meaningful. We believe this goal can be accomplished by allowing MIPS eligible clinicians the flexibility of using third party intermediaries to collect or submit data on their behalf. Specifically, qualified registries, QCDRs, health IT vendors that obtain data from an eligible clinician's certified EHR technology, and CMS-approved survey vendors as discussed in the following proposed policies. In this section, we are specifying the requirements that must be met to become a third party intermediary.

In the PQRS program, quality measures data may be collected or submitted by third party vendors on behalf of an individual EP or group by: (1) A registry; (2) a QCDR; or (3) an EHR vendor that obtains data from an EP's certified EHR technology; or (4) a CMS-approved survey vendor. We propose at § 414.1400(a)(1) that MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician or group by: (1) A qualified registry; (2) a QCDR; (3) a health IT vendor; or (4) a CMS-approved survey vendor. Furthermore, we propose at § 414.1400(a)(3) that third party intermediaries must meet all the requirements designated by CMS as a condition of their qualification or approval to participate in MIPS as a third party intermediary. As proposed at § 414.1400(a)(3)(ii), all submitted data must be submitted in the form and manner specified by CMS.

In the MIPS and APMs RFI, we solicited feedback on how we should address data integrity, testing and standards, and review and qualification processes for QCDRs. Subsequently, we also met with several organizations that were either a QCDR or are in the process of becoming a QCDR. Commenters agreed that data quality is a critical issue for QCDRs. To address some of the data quality concerns, some commenters suggested having processes in place in advance of reporting that could mitigate data errors. For example, this could include a process to reconcile TIN and NPI combinations. Several commenters also suggested limiting submission mechanisms to one submission mechanism per performance category to the extent possible. Commenters generally agreed that QCDRs should be required to submit data using uniform submission standards, with several suggesting the use of the Quality Reporting Document Architecture (QRDA) standard, which certified EHR technology is required to support.

Most commenters noted that uniform standards would ease participation by MIPS eligible clinicians and reduce barriers to entry. Others noted that we should work with ONC and the standards development organization Health Level Seven (HL7) to improve the QRDA standard for current submissions, and that in the future, we should prepare to support emerging standards such as Fast Healthcare Interoperability Resources. Commenters also noted that use of QRDA will align CMS requirements and ONC certification requirements as ONC's 2015 Edition Certification requires that all health information technology (IT) modules used for the submission of CQM data must at least be certified to the QRDA standard. Requiring QCDRs to use QRDA could help reduce vendor interface costs for MIPS eligible clinicians already using certified EHR technology and who desire to participate in registry reporting. Commenters also directed our attention towards the 2015 Edition Certification for additional information on improved test methods and to address historic issues and inaccuracies observed with past calculation and reporting of quality and performance data. With regard to testing, commenters were divided about whether we should require QCDR-specific testing. Several noted that certified EHR technology that support QCDRs have been tested already and that onerous testing may discourage participation. Commenters in favor of testing recommended a degree of flexibility in the early years of the program. Suggestions for testing included the use of comprehensive specifications and accurate testing tools far enough in advance of the performance period to allow developers and implementers to conduct robust testing. These specifications could be included in an Implementation Guide. Opportunities for early testing, using sample data was also emphasized. Commenters did express concern on the amount of time needed for troubleshooting and fixing errors early enough in the testing process such as format, content, and measure accuracy. Commenters suggested several ways we might implement testing, recommending that we:

Test the accuracy, completeness, and reliability of measure calculations for specific, individual measures.

Test the feasibility of data collection requirements.

Pilot new CQMs before release; establish a regular schedule of CQM revisions, and ensure adequate time is allowed for implementation of the revisions.

Align the ONC Health IT Certification program and CMS testing requirements for data submission.

There was a strong consensus that MIPS eligible clinicians should not be penalized for signing up with an entity that purported to offer reliable services but then was unable to accurately submit data to us. Several commenters suggested that entities that do not meet Start Printed Page 28281standards move to a probationary phase and eventually be prohibited from periods of future participation until standards are met. However, commenters also cautioned us not to move too quickly in moving entities to a probationary phase because many QCDRs are run by medical specialty societies and if they were to be disqualified to the detriment of physicians participating, it would also diminish physician enthusiasm for future submission of data.

Commenters had mixed responses regarding how to resolve inaccurate data submission problems when time did not allow for continued review. Commenters felt we should use a “trust but validate” methodology, allowing the QCDR to recalculate the performance rate or authorizing us to do so, but also that we should have validation processes in place as well once the recalculation of the performance rate occurs. Ultimately, we would need to be able to calculate all rates based on a submitted numerator and denominator. Commenters suggested that MIPS eligible clinicians should be assessed an average score or a “pass” for the MIPS quality performance category if data problems cannot be resolved in a timely manner or at the least not be penalized due to data errors outside their control. One commenter suggested use of a Data Quality Management (DQM) program for MIPS eligible clinicians that includes early data qualification evaluation processes to take advantage of feedback and assessments with thresholds for acceptance of data. MIPS eligible clinicians who demonstrate effort toward achieving high quality data submissions but were not able to meet the threshold should be chaperoned to that target and provided with guidance.

Commenters were also divided about our review and qualification of QCDRs to ensure our form and manner requirements are met. Several commenters were concerned with a CMS process in addition to an ONC certification process and recommended we work with ONC to align their certification to address our requirements for QCDRs. Commenters suggested that we also develop more robust implementation guides, and enhance our submission engine validation tool (SEVT).

a. Qualified Clinical Data Registries (QCDRs)

Section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the CPS methodology, to encourage MIPS eligible clinicians to report on applicable measures with respect to the quality performance category through the use of certified EHR technology and QCDRs. Section 1848(q)(2)(B)(iii)(II) of the Act requires that the CPIA subcategories specified by the Secretary include population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR. Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the provision of performance feedback through QCDRs.

Section 1848(m)(3)(E)(i) of the Act requires the Secretary to establish requirements for an entity to be considered a QCDR, which must include a requirement that the entity provide the Secretary with such information, at such times, and in such manner, as the Secretary determines necessary to carry out section 1848(m) of the Act. Section 1848(m)(3)(E)(iv) of the Act requires the Secretary to consult with interested parties in carrying out section 1848(m)(3)(E) of the Act.

Currently, the QCDR reporting mechanism provides a method to satisfy PQRS requirements based on satisfactory participation. We propose that entities interested in becoming a QCDR for MIPS go through a qualification process. This includes the QCDR meeting the definition of a QCDR, self-nomination requirements, and the requirements of a QCDR, including the deadlines listed below. This qualification process allows us to ensure that the entity has the capability to successfully report MIPS eligible clinicians' data to us and allows for review and approval of the QCDR's proposed non-MIPS quality measures. We intend to compile and post a list of entities that we “qualify” to submit data to us as a QCDR for purposes of MIPS on a Web site maintained by CMS.

Section 1848(q)(1)(E) of the Act encourages the use of QCDRs in carrying out the MIPS. Although section 1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to encourage MIPS eligible clinicians to use QCDRs to report on applicable measures with respect to the quality performance category and section 1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the provision of performance feedback through QCDRs, the statute does not specifically address usage of QCDRs for the other MIPS performance categories. Although we could limit the usage of QCDRs to assessing the quality performance category under MIPS and providing performance feedback, we believe it would be less burdensome for MIPS eligible clinicians if we expand the QCDRs capabilities. By allowing QCDRs to report on the quality, advancing care information, and CPIA performance categories we would alleviate the need for individual MIPS eligible clinicians and groups to use a separate mechanism to report data for these performance categories. It is important to note that no data will need to be reported for the resource use performance category since these measures are administrative claims-based. Therefore, we are proposing at § 414.1400(a)(2) to expand QCDRs' capabilities by allowing QCDRs to submit data on measures, activities, or objectives for any of the following MIPS performance categories:

(i) Quality;

(ii) CPIA; or

(iii) Advancing care information, if the MIPS eligible clinician or group is using certified EHR technology.

We believe this approach would permit a single QCDR to report on the quality, advancing care information, and CPIA performance category requirements for MIPS and should mitigate the risks, costs, and burden of MIPS eligible clinicians having to report multiple times to meet the requirements of MIPS.

We propose to define a QCDR at § 414.1305 as a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical and/or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. Examples of the types of entities that may qualify as QCDRs include, but are not limited to, regional collaboratives and specialty societies using a commercially available software platform, as appropriate.

(1) Establishment of an Entity Seeking To Qualify as a QCDR

We propose at § 414.1400(c) the establishment of a QCDR entity is required as follows: for an entity to become qualified for a given performance period as a QCDR, the entity must be in existence as of January 1 of the performance period for which the entity seeks to become a QCDR (for example, January 1, 2017, to be eligible to participate for purposes of performance periods beginning in 2017). The QCDR must have at least 25 participants by January 1 of the performance period. These participants do not need to be using the QCDR to report MIPS data to us; rather, they need to be submitting data to the QCDR for quality improvement.Start Printed Page 28282

(2) Self-Nomination Period

For the 2017 performance period we propose at § 414.1400(b) a self-nomination period from November 15, 2016 until January 15, 2017. For future years of the program, starting with the 2018 performance period, we propose to establish the self-nomination period from September 1 of the prior year until November 1 of the prior year. Entities that desire to qualify as a QCDR for the purposes of MIPS for a given performance period would need to self-nominate for that year and provide all information requested by CMS at the time of self-nomination. Having qualified as a QCDR in a prior year does not automatically qualify the entity to participate in MIPS as a QCDR in subsequent performance periods. For example, a QCDR may choose not to continue participation in the program in future years, or the QCDR may be precluded from participation in a future year due to multiple data or submission errors as noted below. Finally, QCDRs may want to update or change the measures or services or performance categories they intend to provide. As such, CMS believes an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.

We propose to require other information (described below) of QCDRs at the time of self-nomination. If an entity becomes qualified as a QCDR, they will need to sign a statement confirming this information is correct prior to listing it on their Web site. Once we post the QCDR on our Web site, including the services offered by the QCDR, we will require the QCDR to support these services/measures for its clients as a condition of the entity's qualification as a QCDR for purposes of MIPS. Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year.

(3) Information Required at the Time of Self-Nomination

We propose that a QCDR must provide the following information to us at the time of self-nomination to ensure that QCDR data is valid:

Organization Name (Specify Sponsoring Organization name and software vendor name if the two are different. For example, a specialty society in collaboration with a software vendor).

Provide the method(s) by which the entity obtains data from its customers for each performance category for which it is approved: Claims, web-based tool, practice management system, certified EHR technology, other (please explain). If a combination of methods (Claims, web-based tool, Practice Management System, certified EHR technology, and/or other) is utilized, the entity should state which method(s) it utilizes to collect data (for example, perf